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U.S. Department of Health and Human Services

Enforcement Report - Week of November 27, 2013

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Product Type Product Description Code Info Classification Reason for Recall Recalling Firm
Biologics Platelet Apheresis GS34744 Class II Blood product, with insufficient plasma to support the platelet yield, was distributed. Blood Bank Of San Bernardino And Riverside Counties
Biologics Leuko-reduced red cells GZ02161 Class II Blood product, collected from a donor who reported post donation illness, was distributed. Blood Bank Of San Bernardino and Riverside Counties
Biologics Red Blood Cells (Apheresis) Leukocytes Reduced FT02001; FT02010; FT02003; FT02014; FT02013; FT02004; FT02005; FT02012; FT02015; FT02016; FT02017; FT02018; FT02020; FT02022 FT02009; FT02011; FT02025; FT02026; FT02028; FT02030; FT02034 FT02033; FT02035; FT02037; FT02038; FT02039; FT02040; FT02041 FT02043; FT02044; FT02048; FT02050; FT02049; FT02052; FT02068 FT02066; FT02058; FT02060; FT02062; FT02064; FT02070; FT02071 FT02072; FT02075; FT02082; FT02088; FT02094; FT02076; FT02099 FT02097;  ...
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Class III Blood products, not prepared in accordance with specifications, were distributed. American National Red Cross (The)
Biologics Red Blood Cells (Apheresis) Leukocytes Reduced, Irradiated FT03086; FT02664; FT02845; FT03023; FT03763; FT04221; FT04217; FT16827; FT17393; FT17394; FM11041; FT17422; FT17439 Class III Blood products, not prepared in accordance with specifications, were distributed. American National Red Cross (The)
Biologics Fresh Frozen Plasma 6158519 Class III Blood product, prepared from a whole blood unit that had an extended bleed time documented, was distributed. HemaCare Corporation
Biologics Platelets Pheresis Leukocytes Reduced 368525147 Class II Blood product, inappropriately stored in one platelet bag instead of two, was distributed. Blood Systems, Inc.
Biologics Platelets Pheresis Leukocytes Reduced Unit number 4084302 Class II Blood product, collected from a donor who had taken an aspirin-like medication, was distributed. Northwest Florida Blood Center, Inc.
Biologics Red Blood Cells Leukocytes Reduced 4936348 Class II Blood product, collected from a donor who reported travel to an area that was endemic for malaria, was distributed. Florida's Blood Centers, Inc.
Biologics Red Blood Cells (Apheresis) Leukocytes Reduced 107187743- part 2 Class II Blood products, failed to meet specifications for product volume, were distributed. Blood Systems, Inc.
Biologics Red Blood Cells Leukocytes Reduced 107192045 Class III Blood products, failed to meet specifications for product volume, were distributed. Blood Systems, Inc.
Biologics Red Blood Cells 084GS72263 Class III Blood products, collected from a donor for whom there was no documentation of an arm inspection, were distributed. American National Red Cross (The)
Biologics Red Blood Cells Leukocytes Reduced GZ15170 Class III Blood product, manufactured without additive solution, was distributed. Blood Bank of San Bernardino and Riverside Counties
Biologics Blood and Blood Products for Reprocessing 21KS72981 Class II Blood products, collected from a previously deferred donor, were distributed. American National Red Cross (The)
Biologics Red Blood Cells Leukocytes Reduced 21KS72981 Class II Blood products, collected from a previously deferred donor, were distributed. American National Red Cross (The)
Biologics Cryoprecipitate AHF 21KS72981 Class II Blood products, collected from a previously deferred donor, were distributed. American National Red Cross (The)
Biologics Red Blood Cells (Apheresis) Leukocytes Reduced 103412622 Class II Blood product, labeled as leukoreduced was not tested to verify the White Blood Cell count, was distributed. Blood Systems, Inc.
Biologics Source Plasma 359008792, 359015722, 359007620, 359013429, 359007845, 359009707, 359010056, 359010344, 359011161, 359004482, 359010329, 359010451, 359007735, 359008365, 359009515, 359009594, 359009709, 359010036, 359010608, 359007721, 359008310, 359010375, 359011676, 359004489, 359010079, 359010293, 359010388, 359013752, 359013161, 359007755. 359014070, 359015899, 359009149, 359014093, 359015177, 359009445, 359012320, 359012937, 359011380, 359007934, 359012905, 359010849, 359008546, 359008543, 359013638, 359013124, 359012468, 359012165, 359011618, 359011536,  ...
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Class III Blood products, collected from a donor in which donor suitability was not adequately determined, were distributed. Talercris Plasma Resources, Inc.
Biologics Platelets Pheresis Leukocytes Reduced Irradiated 06KN54134; 06KN54138; 06KN54139; 06KN54140; 06KN54122; 06KN54125; 06KN54127; 06KN54130; 06KN54131; 06KN54134; 06KN54138; 06KN54140 Class III Blood products, which may have been exposed to unacceptable storage temperatures, were distributed. American National Red Cross (The)
Biologics Platelets Pheresis Leukocytes Reduced 06KN54122; 06KN54125; 06KN54127; 06KN54130; 06KN54131; 06KN54134; 06KN54138; 06KN54140; 06KN54137; 06KN54141; 06KN54146; 06KN54121 06KN54122; 06KN54126; 06KN54127; 06KN54136; 06KN54137; 06KN54141 06KN54143; 06KN54147 Class III Blood products, which may have been exposed to unacceptable storage temperatures, were distributed. American National Red Cross (The)
Food Big Burst Orange Drink in a 16 oz PET bottle with a sports cap, American Beverage Corp., Verona, PA. Products bearing a "best buy" or "expiration date" earlier than 09/24/12 ONLY: UPCs - 073798001016 Class II There is a possibility that a part of the nozzle cap of the bottle can become dislodged through abuse (i.e. excessive chewing) then possibly ingested, posing a potential health/safety hazard. The cap in question is no longer used by ABC and was last produced in September of 2011. Firm does not anticipate finding any impacted product in the market. American Beverage Corp
Food Big Hug, Fruit Barrel Orange in a plastic 16 oz bottle with a sports cap, American Beverage Corp., Verona, PA. Products bearing a "best buy" or "expiration date" earlier than 09/24/12 ONLY: UPCs - 074806001585 Class II There is a possibility that a part of the nozzle cap of the bottle can become dislodged through abuse (i.e. excessive chewing), and then possibly ingested, posing a potential health/safety hazard. The cap in question is no longer used by ABC and was last produced in September of 2011. Firm does not anticipate finding any impacted product in the market. American Beverage Corp
Food Guzzler Lemonade 20 fl. oz. PET plastic bottle with a sports cap, American Beverage Corporation, Verona PA. The following product bearing a "best buy" or "expiration date" earlier than 09/24/12 ONLY: Flavor and UPC code: Lemonade, 018397000060 Class II There is a possibility that a part of the nozzle cap of the bottle can become dislodged through abuse (i.e. excessive chewing) then possibly ingested, and posing a potential health/safety hazard. The cap in question is no longer used by ABC and was last produced in September of 2011. Firm does not anticipate finding any impacted product in the market. American Beverage Corp
Food Guzzler Concord Grape 20 fl. oz. PET plastic bottle with a sports cap, American Beverage Corporation, Verona PA. The following product bearing a "best buy" or "expiration date" earlier than 09/24/12 ONLY: Flavor and UPC code: Concord Grape, 018397000039 Class II There is a possibility that a part of the nozzle cap of the bottle can become dislodged through abuse (i.e. excessive chewing) then possibly ingested, and posing a potential health/safety hazard. The cap in question is no longer used by ABC and was last produced in September of 2011. Firm does not anticipate finding any impacted product in the market. American Beverage Corp
Food Guzzler Island Punch 20 fl. oz. PET plastic bottle with a sports cap, American Beverage Corporation, Verona PA. The following product bearing a "best buy" or "expiration date" earlier than 09/24/12 ONLY: Flavor and UPC code: Island Punch, 018397000015 Class II There is a possibility that a part of the nozzle cap of the bottle can become dislodged through abuse (i.e. excessive chewing) then possibly ingested, and posing a potential health/safety hazard. The cap in question is no longer used by ABC and was last produced in September of 2011. Firm does not anticipate finding any impacted product in the market. American Beverage Corp
Food Guzzler Iced Tea 20 fl. oz. PET plastic bottle with a sports cap, American Beverage Corporation, Verona PA. The following product bearing a "best buy" or "expiration date" earlier than 09/24/12 ONLY: Flavorand UPC code: Iced Tea, 018397000077 Class II There is a possibility that a part of the nozzle cap of the bottle can become dislodged through abuse (i.e. excessive chewing) then possibly ingested, and posing a potential health/safety hazard. The cap in question is no longer used by ABC and was last produced in September of 2011. Firm does not anticipate finding any impacted product in the market. American Beverage Corp
Food Guzzler Kiwi-Strawberry, 20 fl. oz. PET plastic bottle with a sports cap, American Beverage Corporation, Verona PA. The following product bearing a "best buy" or "expiration date" earlier than 09/24/12 ONLY: Flavor and UPC code: Kiwi-Strawberry, 018397000022 Class II There is a possibility that a part of the nozzle cap of the bottle can become dislodged through abuse (i.e. excessive chewing) then possibly ingested, and posing a potential health/safety hazard. The cap in question is no longer used by ABC and was last produced in September of 2011. Firm does not anticipate finding any impacted product in the market. American Beverage Corp
Food Guzzler Alpine Freeze, 20 fl. oz. PET plastic bottle with a sports cap, American Beverage Corporation, Verona PA. The following product bearing a "best buy" or "expiration date" earlier than 09/24/12 ONLY: Flavor and UPC code: Alpine Freeze, 018397000091. Class II There is a possibility that a part of the nozzle cap of the bottle can become dislodged through abuse (i.e. excessive chewing) then possibly ingested, and posing a potential health/safety hazard. The cap in question is no longer used by ABC and was last produced in September of 2011. Firm does not anticipate finding any impacted product in the market. American Beverage Corp
Food Guzzler Orchard Chill, 20 fl. oz. PET plastic bottle with a sports cap, American Beverage Corporation, Verona PA. The following product bearing a "best buy" or "expiration date" earlier than 09/24/12 ONLY: Flavor and UPC code: Orchard Chill, 018397000107 Class II There is a possibility that a part of the nozzle cap of the bottle can become dislodged through abuse (i.e. excessive chewing) then possibly ingested, and posing a potential health/safety hazard. The cap in question is no longer used by ABC and was last produced in September of 2011. Firm does not anticipate finding any impacted product in the market. American Beverage Corp
Food Guzzler Citrus Punch, 20 fl. oz. PET plastic bottle with a sports cap, American Beverage Corporation, Verona PA. The following product bearing a "best buy" or "expiration date" earlier than 09/24/12 ONLY: Flavor and UPC code: Citrus Punch, 018397000138 Class II There is a possibility that a part of the nozzle cap of the bottle can become dislodged through abuse (i.e. excessive chewing) then possibly ingested, and posing a potential health/safety hazard. The cap in question is no longer used by ABC and was last produced in September of 2011. Firm does not anticipate finding any impacted product in the market. American Beverage Corp
Food Big Juicy Blue Raspberry Drink in 10 oz plastic bottle with a sports cap, American Beverage Corporation, Verona PA. Products bearing a "best buy" or "expiration date" earlier than 09/24/12 ONLY. Class II There is a possibility that a part of the nozzle cap of the bottle can become dislodged through abuse (i.e. excessive chewing) then possibly ingested, and posing a potential health/safety hazard. The cap in question is no longer used by ABC and was last produced in September of 2011. Firm does not anticipate finding any impacted product in the market. American Beverage Corp
Food Big Juicy Grape Drink in 10 oz plastic bottle with a sports cap, American Beverage Corporation, Verona PA. Products bearing a "best buy" or "expiration date" earlier than 09/24/12 ONLY, UPC code 074806170014. Class II There is a possibility that a part of the nozzle cap of the bottle can become dislodged through abuse (i.e. excessive chewing) then possibly ingested, and posing a potential health/safety hazard. The cap in question is no longer used by ABC and was last produced in September of 2011. Firm does not anticipate finding any impacted product in the market. American Beverage Corp
Food Big Juicy Orange Drink in 10 oz plastic bottle with a sports cap, American Beverage Corporation, Verona PA. Products bearing a "best buy" or "expiration date" earlier than 09/24/12 ONLY, UPC code 074806170007. Class II There is a possibility that a part of the nozzle cap of the bottle can become dislodged through abuse (i.e. excessive chewing) then possibly ingested, and posing a potential health/safety hazard. The cap in question is no longer used by ABC and was last produced in September of 2011. Firm does not anticipate finding any impacted product in the market. American Beverage Corp
Food Big Juicy Fruit Punch Drink in 10 oz plastic bottle with a sports cap, American Beverage Corporation, Verona PA. Products bearing a "best buy" or "expiration date" earlier than 09/24/12 ONLY, UPC code 074806170021. Class II There is a possibility that a part of the nozzle cap of the bottle can become dislodged through abuse (i.e. excessive chewing) then possibly ingested, and posing a potential health/safety hazard. The cap in question is no longer used by ABC and was last produced in September of 2011. Firm does not anticipate finding any impacted product in the market. American Beverage Corp
Food Big Hug Fruit Barrel Grape in a 16 oz plastic bottle with a sports cap, American Beverage Corp., Verona PA. Products bearing a "best buy" or "expiration date" earlier than 09/24/12 ONLY: UPC- 074806001592 Class II There is a possibility that a part of the nozzle cap of the bottle can become dislodged through abuse (i.e. excessive chewing) then possibly ingested, and posing a potential health/safety hazard. The cap in question is no longer used by ABC and was last produced in September of 2011. Firm does not anticipate finding any impacted product in the market. American Beverage Corp
Food Big Hug Fruit Barrel Fruit Punch in a 16 oz plastic bottle with a sports cap, American Beverage Corp., Verona PA. Products bearing a "best buy" or "expiration date" earlier than 09/24/12 ONLY: UPC- 074806001608 Class II There is a possibility that a part of the nozzle cap of the bottle can become dislodged through abuse (i.e. excessive chewing) then possibly ingested, and posing a potential health/safety hazard. The cap in question is no longer used by ABC and was last produced in September of 2011. Firm does not anticipate finding any impacted product in the market. American Beverage Corp
Food Big Hug Fruit Barrel Citrus in a 16 oz plastic bottle with a sports cap, American Beverage Corp., Verona PA. Products bearing a "best buy" or "expiration date" earlier than 09/24/12 ONLY: UPC- 074806001691. Class II There is a possibility that a part of the nozzle cap of the bottle can become dislodged through abuse (i.e. excessive chewing) then possibly ingested, and posing a potential health/safety hazard. The cap in question is no longer used by ABC and was last produced in September of 2011. Firm does not anticipate finding any impacted product in the market. American Beverage Corp
Food Big Hug Fruit Barrel Kiwi Strawberry, in a 16 oz plastic bottle with a sports cap, American Beverage Corp., Verona PA. Products bearing a "best buy" or "expiration date" earlier than 09/24/12 ONLY: UPC- 074806001622 Class II There is a possibility that a part of the nozzle cap of the bottle can become dislodged through abuse (i.e. excessive chewing) then possibly ingested, and posing a potential health/safety hazard. The cap in question is no longer used by ABC and was last produced in September of 2011. Firm does not anticipate finding any impacted product in the market. American Beverage Corp
Food Big Hug Lemonade Fruit Drink in a 16 oz plastic bottle with a sports cap, American Beverage Corp., Verona PA. Products bearing a "best buy" or "expiration date" earlier than 09/24/12 ONLY: UPC- 074806001639 Class II There is a possibility that a part of the nozzle cap of the bottle can become dislodged through abuse (i.e. excessive chewing) then possibly ingested, and posing a potential health/safety hazard. The cap in question is no longer used by ABC and was last produced in September of 2011. Firm does not anticipate finding any impacted product in the market. American Beverage Corp
Food Big Hug Lemon Lime Fruit Drink in a 16 oz plastic bottle with a sports cap, American Beverage Corp., Verona PA. Products bearing a "best buy" or "expiration date" earlier than 09/24/12 ONLY: UPC- 074806001653 Class II There is a possibility that a part of the nozzle cap of the bottle can become dislodged through abuse (i.e. excessive chewing) then possibly ingested, and posing a potential health/safety hazard. The cap in question is no longer used by ABC and was last produced in September of 2011. Firm does not anticipate finding any impacted product in the market. American Beverage Corp
Food Big Hug Fruit Barrel Blue Raspberry in a 16 oz plastic bottle with a sports cap, American Beverage Corp., Verona PA. Products bearing a "best buy" or "expiration date" earlier than 09/24/12 ONLY: UPC- 074806001615 Class II There is a possibility that a part of the nozzle cap of the bottle can become dislodged through abuse (i.e. excessive chewing) then possibly ingested, and posing a potential health/safety hazard. The cap in question is no longer used by ABC and was last produced in September of 2011. Firm does not anticipate finding any impacted product in the market. American Beverage Corp
Food Big Burst Grape Drink in a 16 oz PET plastic bottle with a sports cap, American Beverage Corp., Verona PA. Products bearing a "best buy" or "expiration date" earlier than 09/24/12 ONLY: UPC -073798001023 Class II There is a possibility that a part of the nozzle cap of the bottle can become dislodged through abuse (i.e. excessive chewing) then possibly ingested, and posing a potential health/safety hazard. The cap in question is no longer used by ABC and was last produced in September of 2011. Firm does not anticipate finding any impacted product in the market. American Beverage Corp
Food Big Burst Lemon Lime Drink, in a 16 oz PET plastic bottle with a sports cap, American Beverage Corp., Verona PA. Products bearing a "best buy" or "expiration date" earlier than 09/24/12 ONLY: UPC - 073798001054 Class II There is a possibility that a part of the nozzle cap of the bottle can become dislodged through abuse (i.e. excessive chewing) then possibly ingested, and posing a potential health/safety hazard. The cap in question is no longer used by ABC and was last produced in September of 2011. Firm does not anticipate finding any impacted product in the market. American Beverage Corp
Food Big Burst Fruit Punch Drink, in a 16 oz PET plastic bottle with a sports cap, American Beverage Corp., Verona PA. Products bearing a "best buy" or "expiration date" earlier than 09/24/12 ONLY: UPC-073798001030 Class II There is a possibility that a part of the nozzle cap of the bottle can become dislodged through abuse (i.e. excessive chewing) then possibly ingested, and posing a potential health/safety hazard. The cap in question is no longer used by ABC and was last produced in September of 2011. Firm does not anticipate finding any impacted product in the market. American Beverage Corp
Food Big Burst Blue Raspberry Drink in a 16 oz PET plastic bottle with a sports cap, American Beverage Corp., Verona PA. Products bearing a "best buy" or "expiration date" earlier than 09/24/12 ONLY: UPC-073798001092 Class II There is a possibility that a part of the nozzle cap of the bottle can become dislodged through abuse (i.e. excessive chewing) then possibly ingested, and posing a potential health/safety hazard. The cap in question is no longer used by ABC and was last produced in September of 2011. Firm does not anticipate finding any impacted product in the market. American Beverage Corp
Food Big Burst Kiwi Strawberry Drink in a 16 oz PET plastic bottle with a sports cap, American Beverage Corp., Verona PA. Products bearing a "best buy" or "expiration date" earlier than 09/24/12 ONLY: UPC-073798001207. Class II There is a possibility that a part of the nozzle cap of the bottle can become dislodged through abuse (i.e. excessive chewing) then possibly ingested, and posing a potential health/safety hazard. The cap in question is no longer used by ABC and was last produced in September of 2011. Firm does not anticipate finding any impacted product in the market. American Beverage Corp
Food Big Burst Citrus Punch Drink in a 16 oz PET plastic bottle with a sports cap, American Beverage Corp., Verona PA. Products bearing a "best buy" or "expiration date" earlier than 09/24/12 ONLY: UPC -073798001108 Class II There is a possibility that a part of the nozzle cap of the bottle can become dislodged through abuse (i.e. excessive chewing) then possibly ingested, and posing a potential health/safety hazard. The cap in question is no longer used by ABC and was last produced in September of 2011. Firm does not anticipate finding any impacted product in the market. American Beverage Corp
Devices Centricity Perinatal and Centricity Intensive Care is intended to be used in clinical departments healthcare delivery systems such as a Labor and Delivery, Postpartum Maternal Care, newborn Nursery, critical care units including Neonatal Intensive Care Units (NICU), and may also be used in physicians offices and outpatient clinics. This product is primarily intended to serve the purpose of electronic documentation of clinical data and is designed to accept, transfer, display, calculate, store and manage clinical data. System capabilities provide the user with the ability to acquire data from the medical devices and to document, annotate, display, store, print, export and retrieve patient clinical practice information. This product is intended for professional use only. Centricity Perinatal and Centricity Intensive Care Versions: 6.60, 6.60.9, 6.70.0, 6.70.1, 6.70.5, 6.70.6, 6.80.0, 6.80.1, 6.90.0, 6.90.1, 6.91.1 Class II 1) Under rare network conditions, a Centricity Perinatal process may maintain an incorrect count of Patient slots in use which may lead to an inability to access the patient roster. The user is temporarily unable to review or edit form and chart information. This could result in a potential delay of care; however active fetal strips and permanent patient data storage are not affected. 2) When patient data on a vertical chart exceeds one page (with more rows then can fit on a page), the thumb indicator (Right Scroll Bar) appears to be at the end of the page when there may be more data. Because this information is not viewed, the clinician may not take the data into account when making a clinical decision. However, the bottom right corner of the chart box is displayed when you reach the end of a vertical chart as a visual cue. 3) It is possible for a system manager to misconfigure a coded or multi-coded item with no short text defined. This may have the effect of not presenting the data on the tubular chart display even if the data is set to show long text values. The clinician may not be aware this data exists and therefore may not take into account during clinical decision making. 4) If using a Phillips physiological monitor (not fetal monitor) at a patient's bedside, and data still exists on the monitor from the previous patient, and the clinician selects the "acquire vital signs" action from the Centricity Perinatal system before the initial vital signs are actually taken on the new patient, the monitor buffer sends the last set of vital signs from the previous patient. This data may be stored in the patient record if vital signs do not need to be validated. If this incorrect data is stored to the patient record the clinician may use this data in clinical decision making. 5) The Centricity Perinatal server process (PTD) that manages scheduled tasks may be misconfigured and saved with undefined patient selection criteria. When the criterion for a PTD job is undefined (selected patient or selected unit is "None"), the PTD job may perform actions on a patient that was not intended for the job. The primary concern for customer sites is if they have set up the PTD action as "Purge Only" (with no archive) combined with the undefined selection criteria, they may inadvertently purge a patient record from the system. Due to this configuration error, information that may be used in historical clinical decision making may have been lost and may result in a delay in care while the data is gathered. GE Healthcare It
Devices The Centricity Laboratory System is intended to be an information system designed to support the clinical and administrative activities associated with the provision and utilization of clinical laboratory services and facilities, e.g., the storing and delivering of analytical results. It is a specially designed data program application (software), which is supplied for installation in existing mainframe or decentralized computers or a computer network. This software system will not be the software directly used to run, steer, or control any specific laboratory analyzer or equipment. It is intended for use in laboratory facilities, including a central laboratory or in a multiple laboratory environment servicing satellite laboratories, reference laboratories, clinics, etc. Centricity Laboratory System is not intended for direct patient contact. The Centricity Laboratory System product is designed to facilitate the general clinical, anatomic pathology and cytology laboratory workflow such as order entry, results entry, instrument interfacing, results reporting and patient record retrieval. It integrates with other Hospital Information Systems (HIS) through HL7 interface by order entering and also report processing. The Centricity Laboratory System is intended to interface with various lab results. Centricity Laboratory System is intended to be used by laboratory technologists, technicians, analyst and other trained/site authorized system users Software Versions: 3.3, 4.0, 4.1 Class II GE Healthcare has become aware of a potential safety issue associated with the use of GE Centricity Laboratory where panel reflex does not occur if DIP.Specimen is blank. Panel reflexing fails to occur when ad-hoc re-routing functionality is used and the following are true: 1) The ordered panel is a slave panel, and; 2) The panitem specimen group field of one or more of the ordered items on the master panel is blank instead of null or the panitem specimen group field of one or more of the ordered items on another re-route master panel on the same request is blank instead of null, and; 3) The re-routed batches containing the affected master panels are recieved at the performing lab before the item causing the reflex is resulted. GE Healthcare It
Devices The GemStar Pump is a small and lightweight, single channel infusion device designed for use in the home, in the hospital, or anywhere electronic infusion is required. The GemStar Pump can be powered by AC mains adaptor, rechargeable battery pack, docking station, or two disposable AA alkaline batteries. When powered by batteries, The GemStar Pump is ideal for ambulatory patients. *** 1) List Number 13000, Serial Numbers: 98121336  ...
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Class I The proximal and distal pressure sensor calibration can drift resulting in the pump failing the Proximal or Distal Occlusion Operational Test, as described in the GemStar Technical Service Manual, or reporting one of the following errors during device setup or infusion: 1) Cassette Check - D; 2) Cassette Check - P; 3) Proximal Occlusion; 4) Distal Occlusion; 5) Pressure Calibration Error; 6) Bad Pressure Sensor Event; 7) Bad Pressure State; 8) Distal Pressure is Out of Range; 9) Proximal Sensor is Out of Range. A pump with this issue may, instead of reporting an error, not detected occlusions or issue false occlusion alarms, which will stop the infusion and invoke visual and audible warnings to the user. Hospira Inc.
Devices The GemStar Pump is a small and lightweight, single channel infusion device designed for use in the home, in the hospital, or anywhere electronic infusion is required. The GemStar Pump can be powered by AC mains adaptor, rechargeable battery pack, docking station, or two disposable AA alkaline batteries. When powered by batteries, The GemStar Pump is ideal for ambulatory patients. *** 1) List Number: 13086, Serial Numbers: 15651117 , 15651119 , 15651121, 15651122 , 15651124 , 15651125 , 15651128 , 15651129 , 15651131 , 15651134 , 15651138 , 15651140 , 15651123 , 15651132 , 15651133 , 15651136 , 15651137 , 15651139 , 15651116 , 15651118 , 15651120 , 15651126 ,  ...
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Class I The proximal and distal pressure sensor calibration can drift resulting in the pump failing the Proximal or Distal Occlusion Operational Test, as described in the GemStar Technical Service Manual, or reporting one of the following errors during device setup or infusion: 1) Cassette Check - D; 2) Cassette Check - P; 3) Proximal Occlusion; 4) Distal Occlusion; 5) Pressure Calibration Error; 6) Bad Pressure Sensor Event; 7) Bad Pressure State; 8) Distal Pressure is Out of Range; 9) Proximal Sensor is Out of Range. A pump with this issue may, instead of reporting an error, not detected occlusions or issue false occlusion alarms, which will stop the infusion and invoke visual and audible warnings to the user. Hospira Inc.
Drugs Affirm XL Nutritional Supplement, 1 and 10 count blister packs and single pill packs, Manufactured by Dongseo Biopharm Corp., Yongin City, Kyonggi do, Korea, distributed by: Affirm XL, LLC, Ladera Ranch, CA Lot# 1190001, exp 12/30/2013 Class I Marketed Without An Approved NDA/ANDA: FDA analysis found the product to contain sulfoaildenafil, an analogue of sildenafil which is an ingredient in an FDA-approved drug for the treatment of male erectile dysfunction, making this an unapproved new drug. Affirm XL, Inc.
Devices Olympus Endoscopic Flushing Pump, Model OPF-2. Facilitates washing of tissues to remove blood, feces and other organic matter during endoscopic procedures. Model OPF-2 with serial numbers: 21301567 21301799 21220870 21220876 21220878 21220869 21301569 21220788 21220710 21220712 21220181 21220707 21301315 21301216 21301672 21301675 21301793 21301795 21301960 21303157 21303159 21303161 21303388 21303390 21303391 21301064 21221126 21301053 21301059 21301570 21301573 21301054 21220701 21301066 21301203 21301205 21301209 21301673 21220706 21301572 21301052 21301055 21301065 21301571 21220953 21302798 21302917 21302920 21302925 21303009 21303017 21301058 21301060 21301485 21301493 21301566 21301408 21301961 21301804 21221123 21301317 21301483 21301217 21301320 21301482 21301214 21220357 21301062 21220179 21220171 21220789 21301487 21301489 21303156 21220877 21301413 21220176 21220711 21302919 21301796 21301797 21301415 21301963 21220174 21220168 21220704 21301056 21220621 21301204 21301207 21301212 21301215 21301575 21301206 21301213 21301321 21301322 21301406 21301484 21301568 21220709 21301409 21301404 21303162 21220790 21302791 21301414 21301407 21220785 21301410 21301210 21301211 21303010 21303014 21301411 21301577 21301208 21302921 21302923 21303013 21303397 21301316 21220868 21220787 21302910 21302911 21302912 21302915 21302918 21302974 21303012 21302913 21302922 21302924 21302973 21303008 21303015 21301490 21301492 21221124 21301957 21301959 21301965 21301966 21301967 21301968 21220169 21220951 21220963 21301313 21303016 21301798 21301486 21301488 21301491 21220615 21220618 21220625 21221125 21302914 21220871 21220880 21301405 21221122 21220175 21302916 21303158 21303160 21303387 21303392 21303393 21303396 21303398 21220180 21220708 21301674 21220702 21220616 21220623 21220783 21220793 21220178 21220613 21220620 21301962 21220865 21301958 21220260 21302971 21303389 21301061 21220872 21220875 21220879 21220952 21220954 21220955 21220956 21220957 21220958 21220959 21220960 21220961 21220962 21220964 21220965 21302792 21220172 21220866 21302972 21303011 21301794 21301800 21301802 21301803 21301319 21301412 21301574 21301801 21303394 21303395 21220624 21220791 21301318 21220703 21220263 21220614 21220786 21302793 21302794 21302789 21302796 21301576 21220170 21220262 21220358 21220705 21220713 Class II There is a possibility that the pump head was not shipped in the locked position. If the pump head is in an unlocked position this may, under certain circumstances, cause the pump to stop and go into power stand-by mode. Olympus America Inc.
Biologics Red Blood Cells Leukocytes Reduced W227013012155 Class II Blood product, collected from a donor in which donor suitability was not adequately determined, was distributed. Community Blood Center of Carolinas
Biologics Red Blood Cells Leukocytes Reduced W227012040047 Class II Blood products, collected from a donor who received a piercing within 12 months of donation, were distributed. Community Blood Center of Carolinas
Biologics Fresh Frozen Plasma W227012040047 Class II Blood products, collected from a donor who received a piercing within 12 months of donation, were distributed. Community Blood Center of Carolinas
Biologics Blood and Blood Products for Reprocessing W067313001392 Class III Blood product, which was collected from a donor in which donor suitability was not adequately determined, was distributed. Coffee Memorial Blood Center
Devices VITROS Chemistry Products ACET Slides, 90 slides/pack; catalog number 1037274 VITROS Chemistry Products ACET Slides quantitatively measure acetaminophen (ACET) concentration in serum and plasma using VITROS 250/350/950/5,1 FS and 4600 Chemistry Systems and the VITROS 5600 Integrated System. Multiple lots affected, with expiry dates through 22-Mar-2015 Class II Ortho Clinical Diagnostics is recalling Slide Dispense cartridges used with some VITROS Chemistry Product Slides due to slide dispense issues. Ortho-Clinical Diagnostics
Devices VITROS Chemistry Products AcP Slides, 90 slides/pack; catalog number 8168122 VITROS Chemistry Products AcP Slides quantitatively measure acid phosphatase (AcP) activity in serum and plasma using VITROS 950/5,1 FS and 4600 Chemistry Systems and the VITROS 5600 Integrated System. Multiple lots affected, with expiry dates through 22-Mar-2015 Class II Ortho Clinical Diagnostics is recalling Slide Dispense cartridges used with some VITROS Chemistry Product Slides due to slide dispense issues. Ortho-Clinical Diagnostics
Devices VITROS Chemistry Products ALB Slides, 90 slides/pack; catalog number 1988211 VITROS ALB Slides quantitatively measure (ALB) concentration in serum and plasma using VITROS 250/350/950/5,1 FS and 4600 Chemistry Systems and the VITROS 5600 Integrated System. Multiple lots affected, with expiry dates through 22-Mar-2015 Class II Ortho Clinical Diagnostics is recalling Slide Dispense cartridges used with some VITROS Chemistry Product Slides due to slide dispense issues. Ortho-Clinical Diagnostics
Devices VITROS Chemistry Products ALC Slides, 90 slides/pack; catalog number 8046872 VITROS ALC Slides quantitatively measure ethanol (ALC) concentration in serum and plasma using VITROS 250/350/950/5,1 FS and 4600 Chemistry Systems and the VITROS 5600 Integrated System. Multiple lots affected, with expiry dates through 22-Mar-2015 Class II Ortho Clinical Diagnostics is recalling Slide Dispense cartridges used with some VITROS Chemistry Product Slides due to slide dispense issues. Ortho-Clinical Diagnostics
Devices VITROS Chemistry Products ALKP Slides, 300 slides/pack; catalog number 1053180 VITROS ALKP Slides quantitatively measure alkaline phosphatase (ALKP) activity in serum and plasma using VITROS 250/350/950/5,1 FS and 4600 Chemistry Systems and the VITROS 5600 Integrated System. Multiple lots affected, with expiry dates through 22-Mar-2015 Class II Ortho Clinical Diagnostics is recalling Slide Dispense cartridges used with some VITROS Chemistry Product Slides due to slide dispense issues. Ortho-Clinical Diagnostics
Devices VITROS Chemistry Products AMON Slides packaged as 300 slides/pack catalog number 1721869 and packaged as 90 slides/pack catalog number 1726926 VITROS AMON Slides quantitatively measure ammonia concentration in plasma using VITROS 250/350/950/5,1 FS and 4600 Chemistry Systems and the VITROS 5600 Integrated System. Multiple lots affected, with expiry dates through 22-Mar-2015 Class II Ortho Clinical Diagnostics is recalling Slide Dispense cartridges used with some VITROS Chemistry Product Slides due to slide dispense issues. Ortho-Clinical Diagnostics
Devices VITROS Chemistry Products AMYL Slides packaged as 300 slides/pack catalog number 1202670 and packaged as 90 slides/pack catalog number 8112724 VITROS AMYL Slides quantitatively measure amylase (AMYL) activity in serum, plasma, and urine using VITROS 250/350/950/5,1 FS and 4600 Chemistry Systems and the VITROS 5600 Integrated System. Multiple lots affected, with expiry dates through 22-Mar-2015 Class II Ortho Clinical Diagnostics is recalling Slide Dispense cartridges used with some VITROS Chemistry Product Slides due to slide dispense issues. Ortho-Clinical Diagnostics
Devices VITROS Chemistry Products AST Slides packaged as 300 slides/pack catalog number 8433815 VITROS AST Slides quantitatively measure aspartate aminotransferase (AST) activity in serum and plasma using VITROS 250/350/950/5,1 FS and 4600 Chemistry Systems and the VITROS 5600 Integrated System Multiple lots affected, with expiry dates through 22-Mar-2015 Class II Ortho Clinical Diagnostics is recalling Slide Dispense cartridges used with some VITROS Chemistry Product Slides due to slide dispense issues. Ortho-Clinical Diagnostics
Devices VITROS Chemistry Products BuBc Slides packaged as 300 slides/pack catalog number 8383051 and packaged as 90 slides/pack catalog number 1612365 VITROS BuBc Slides quantitatively measure unconjugated bilirubin (Bu) and conjugated bilirubin (Bc) concentrations in serum and plasma using VITROS 250/350/950/5,1 FS and 4600 Chemistry Systems and the VITROS 5600 Integrated System. Multiple lots affected, with expiry dates through 22-Mar-2015 Class II Ortho Clinical Diagnostics is recalling Slide Dispense cartridges used with some VITROS Chemistry Product Slides due to slide dispense issues. Ortho-Clinical Diagnostics
Devices VITROS Chemistry Products BUN/UREA Slides packaged as 300 slides/pack catalog number 8102204 VITROS BUN/UREA Slides quantitatively measure urea concentration, reported either as urea nitrogen (BUN) or as urea (UREA), in serum, plasma, and urine using VITROS 250/350/950/5,1 FS and 4600 Chemistry Systems and the VITROS 5600 Integrated System. Multiple lots affected, with expiry dates through 22-Mar-2015 Class II Ortho Clinical Diagnostics is recalling Slide Dispense cartridges used with some VITROS Chemistry Product Slides due to slide dispense issues. Ortho-Clinical Diagnostics
Devices VITROS Chemistry Products Ca Slides packaged as 300 slides/pack catalog number 1450261 VITROS Ca Slides quantitatively measure calcium (Ca) concentration in serum, plasma, and urine using VITROS 250/350/950/5,1 FS and 4600 Chemistry Systems and the VITROS 5600 Integrated System. Multiple lots affected, with expiry dates through 22-Mar-2015 Class II Ortho Clinical Diagnostics is recalling Slide Dispense cartridges used with some VITROS Chemistry Product Slides due to slide dispense issues. Ortho-Clinical Diagnostics
Devices VITROS Chemistry Products CHE Slides packaged as 300 slides/pack catalog number 1914605 and packaged as 90 slides/pack catalog number 8004707 VITROS CHE Slides quantitatively measure cholinesterase (CHE) activity in serum and plasma using VITROS 250/350/950/5,1 FS and 4600 Chemistry Systems and the VITROS 5600 Integrated System. Multiple lots affected, with expiry dates through 22-Mar-2015 Class II Ortho Clinical Diagnostics is recalling Slide Dispense cartridges used with some VITROS Chemistry Product Slides due to slide dispense issues. Ortho-Clinical Diagnostics
Devices VITROS Chemistry Products CHOL Slides packaged as 300 slides/pack catalog number 1669829 VITROS CHOL Slides quantitatively measure cholesterol (CHOL) concentration in serum and plasma using VITROS 250/350/950/5,1 FS and 4600 Chemistry Systems and the VITROS 5600 Integrated System. Multiple lots affected, with expiry dates through 22-Mar-2015 Class II Ortho Clinical Diagnostics is recalling Slide Dispense cartridges used with some VITROS Chemistry Product Slides due to slide dispense issues. Ortho-Clinical Diagnostics
Devices VITROS Chemistry Products CK Slides packaged as 300 slides/pack catalog number 8479396 and packaged as 90 slides/pack catalog number 8478034 VITROS CK Slides quantitatively measure creatine kinase (CK) activity in serum and plasma using VITROS 250/350/950/5,1 FS and 4600 Chemistry Systems and the VITROS 5600 Integrated System. Multiple lots affected, with expiry dates through 22-Mar-2015 Class II Ortho Clinical Diagnostics is recalling Slide Dispense cartridges used with some VITROS Chemistry Product Slides due to slide dispense issues. Ortho-Clinical Diagnostics
Devices VITROS Chemistry Products CK-MB Slides packaged as 300 slides/pack catalog number 8058232 and packaged as 90 slides/pack catalog number 8001133 VITROS CK Slides quantitatively measure creatine kinase (CK) activity in serum and plasma using VITROS 250/350/950/5,1 FS and 4600 Chemistry Systems and the VITROS 5600 Integrated System. Multiple lots affected, with expiry dates through 22-Mar-2015 Class II Ortho Clinical Diagnostics is recalling Slide Dispense cartridges used with some VITROS Chemistry Product Slides due to slide dispense issues. Ortho-Clinical Diagnostics
Devices VITROS Chemistry Products CRBM Slides packaged as 90 slides/pack catalog number 8892382 Multiple lots affected, with expiry dates through 22-Mar-2015 Class II Ortho Clinical Diagnostics is recalling Slide Dispense cartridges used with some VITROS Chemistry Product Slides due to slide dispense issues. VITROS CRBM Slides quantitatively measure carbamazepine (CRBM) concentration in serum and plasma using VITROS 250/350/950/5,1 FS and 4600 Chemistry Systems and the VITROS 5600 Integrated System. Ortho-Clinical Diagnostics
Devices VITROS Chemistry Products CREA Slides packaged as 300 slides/pack catalog number 6802584 VITROS CREA Slides quantitatively measure creatinine (CREA) concentration in serum, plasma, and urine using VITROS 250/350/950/5,1 FS and 4600 Chemistry Systems and the VITROS 5600 Integrated System. Multiple lots affected, with expiry dates through 22-Mar-2015 Class II Ortho Clinical Diagnostics is recalling Slide Dispense cartridges used with some VITROS Chemistry Product Slides due to slide dispense issues. Ortho-Clinical Diagnostics
Devices VITROS Chemistry Products CRP Slides packaged as 90 slides/pack catalog number 8097990 VITROS CRP Slides quantitatively measure C-reactive protein (CRP) concentration in serum and plasma using VITROS 250/350/950/5,1 FS and 4600 Chemistry Systems and the VITROS 5600 Integrated System. Multiple lots affected, with expiry dates through 22-Mar-2015 Class II Ortho Clinical Diagnostics is recalling Slide Dispense cartridges used with some VITROS Chemistry Product Slides due to slide dispense issues. Ortho-Clinical Diagnostics
Devices VITROS Chemistry Products DGXN Slides packaged as 90 slides/pack catalog number 8343386 VITROS DGXN Slides quantitatively measure digoxin (DGXN) concentration in serum using VITROS 250/350/950/5,1 FS and 4600 Chemistry Systems and the VITROS 5600 Integrated System. Multiple lots affected, with expiry dates through 22-Mar-2015 Class II Ortho Clinical Diagnostics is recalling Slide Dispense cartridges used with some VITROS Chemistry Product Slides due to slide dispense issues. Ortho-Clinical Diagnostics
Devices VITROS Chemistry Products dHDL Slides packaged as 300 slides/pack catalog number 6801895 VITROS dHDL Slides quantitatively measure HDL cholesterol (HDLC) concentration in serum and plasma using VITROS 250/350/950/5,1 FS and 4600 Chemistry Systems and the VITROS 5600 Integrated System. Multiple lots affected, with expiry dates through 22-Mar-2015 Class II Ortho Clinical Diagnostics is recalling Slide Dispense cartridges used with some VITROS Chemistry Product Slides due to slide dispense issues. Ortho-Clinical Diagnostics
Devices VITROS Chemistry Products ECO2 Slides packaged as 300 slides/pack catalog number 8262396 VITROS ECO2 Slides quantitatively measure total carbon dioxide (CO2) concentration in serum and plasma using VITROS 250/350/950/5,1 FS and 4600 Chemistry Systems and the VITROS 5600 Integrated System. Multiple lots affected, with expiry dates through 22-Mar-2015 Class II Ortho Clinical Diagnostics is recalling Slide Dispense cartridges used with some VITROS Chemistry Product Slides due to slide dispense issues. Ortho-Clinical Diagnostics
Devices VITROS Chemistry Products Fe Slides packaged as 300 slides/pack catalog number 1515808 and packaged as 90 slides/pack catalog number 1924547 VITROS Fe Slides quantitatively measure iron (Fe) concentration in serum and plasma using VITROS 250/350/950/5,1 FS and 4600 Chemistry Systems and the VITROS 5600 Integrated System. Multiple lots affected, with expiry dates through 22-Mar-2015 Class II Ortho Clinical Diagnostics is recalling Slide Dispense cartridges used with some VITROS Chemistry Product Slides due to slide dispense issues. Ortho-Clinical Diagnostics
Devices VITROS Chemistry Products GLU Slides packaged as 300 slides/pack catalog number 1707801 VITROS GLU Slides quantitatively measure glucose (GLU) concentration in serum, plasma, urine and cerebrospinal fluid using VITROS 250/350/950/5,1 FS and 4600 Chemistry Systems and the VITROS 5600 Integrated System. Multiple lots affected, with expiry dates through 22-Mar-2015 Class II Ortho Clinical Diagnostics is recalling Slide Dispense cartridges used with some VITROS Chemistry Product Slides due to slide dispense issues. Ortho-Clinical Diagnostics
Devices VITROS Chemistry Products LAC Slides packaged as 300 slides/pack catalog number 8433880 and packaged as 90 slides/pack catalog number 8150112 VITROS LAC Slides quantitatively measure lactate (LAC) concentration in plasma using VITROS 250/350/950/5,1 FS and 4600 Chemistry Systems and the VITROS 5600 Integrated System. Multiple lots affected, with expiry dates through 22-Mar-2015 Class II Ortho Clinical Diagnostics is recalling Slide Dispense cartridges used with some VITROS Chemistry Product Slides due to slide dispense issues. Ortho-Clinical Diagnostics
Devices VITROS Chemistry Products Li Slides packaged as 300 slides/pack catalog number 8318925 and packaged as 90 slides/pack catalog number 1632660 VITROS Li Slides quantitatively measure lithium (Li) concentration in serum and plasma using VITROS 250/350/950/5,1 FS and 4600 Chemistry Systems and the VITROS 5600 Integrated System. Multiple lots affected, with expiry dates through 22-Mar-2015 Class II Ortho Clinical Diagnostics is recalling Slide Dispense cartridges used with some VITROS Chemistry Product Slides due to slide dispense issues. Ortho-Clinical Diagnostics
Devices VITROS Chemistry Products LIPA Slides packaged as 300 slides/pack catalog number 1668409 and packaged as 90 slides/pack catalog number 8297749 VITROS LIPA Slides quantitatively measure Lipase (LIPA) activity in serum and plasma using VITROS 250/350/950/5,1 FS and 4600 Chemistry Systems and the VITROS 5600 Integrated System. Multiple lots affected, with expiry dates through 22-Mar-2015 Class II Ortho Clinical Diagnostics is recalling Slide Dispense cartridges used with some VITROS Chemistry Product Slides due to slide dispense issues. Ortho-Clinical Diagnostics
Devices VITROS Chemistry Products Mg Slides packaged as 300 slides/pack catalog number 8255093 and packaged as 90 slides/pack catalog number 1921204 VITROS Mg Slides quantitatively measure magnesium (Mg) concentration in serum, plasma, and urine using VITROS 250/350/950/5,1 FS and 4600 Chemistry Systems and the VITROS 5600 Integrated System. Multiple lots affected, with expiry dates through 22-Mar-2015 Class II Ortho Clinical Diagnostics is recalling Slide Dispense cartridges used with some VITROS Chemistry Product Slides due to slide dispense issues. Ortho-Clinical Diagnostics
Devices VITROS Chemistry Products PHBR Slides packaged as 90 slides/pack catalog number 8221384 VITROS PHBR Slides quantitatively measure phenobarbital (PHBR) concentration in serum and plasma using VITROS 250/350/950/5,1 FS and 4600 Chemistry Systems and the VITROS 5600 Integrated System. Multiple lots affected, with expiry dates through 22-Mar-2015 Class II Ortho Clinical Diagnostics is recalling Slide Dispense cartridges used with some VITROS Chemistry Product Slides due to slide dispense issues. Ortho-Clinical Diagnostics
Devices VITROS Chemistry Products PHOS Slides packaged as 300 slides/pack catalog number 1513209 VITROS PHOS Slides quantitatively measure phosphorus (PHOS) concentration in serum, plasma, and urine using VITROS 250/350/950/5,1 FS and 4600 Chemistry Systems and the VITROS 5600 Integrated System. Multiple lots affected, with expiry dates through 22-Mar-2015 Class II Ortho Clinical Diagnostics is recalling Slide Dispense cartridges used with some VITROS Chemistry Product Slides due to slide dispense issues. Ortho-Clinical Diagnostics
Devices VITROS Chemistry Products PHYT Slides packaged as 90 slides/pack catalog number 8298671 VITROS PHYT Slides quantitatively measure phenytoin (PHYT) concentration in serum and plasma using VITROS 250/350/950/5,1 FS and 4600 Chemistry Systems and the VITROS 5600 Integrated System. Multiple lots affected, with expiry dates through 22-Mar-2015 Class II Ortho Clinical Diagnostics is recalling Slide Dispense cartridges used with some VITROS Chemistry Product Slides due to slide dispense issues. Ortho-Clinical Diagnostics
Devices VITROS Chemistry Products PROT Slides packaged as 90 slides/pack catalog number 8208431 VITROS PROT Slides quantitatively measure protein (PROT) concentration in cerebrospinal fluid using VITROS 250/350/950/5,1 FS and 4600 Chemistry Systems and the VITROS 5600 Integrated System. Multiple lots affected, with expiry dates through 22-Mar-2015 Class II Ortho Clinical Diagnostics is recalling Slide Dispense cartridges used with some VITROS Chemistry Product Slides due to slide dispense issues. Ortho-Clinical Diagnostics
Devices VITROS Chemistry Products SALI Slides packaged as 90 slides/pack catalog number 1314343 VITROS SALI Slides quantitatively measure salicylate (SALI) concentration in serum and plasma using VITROS 250/350/950/5,1 FS and 4600 Chemistry Systems and the VITROS 5600 Integrated System. Multiple lots affected, with expiry dates through 22-Mar-2015 Class II Ortho Clinical Diagnostics is recalling Slide Dispense cartridges used with some VITROS Chemistry Product Slides due to slide dispense issues. Ortho-Clinical Diagnostics
Devices VITROS Chemistry Products TBIL Slides packaged as 300 slides/pack catalog number 8159931 VITROS TBIL Slides quantitatively measure total bilirubin (TBIL) concentration in serum and plasma using VITROS 250/350/950/5,1 FS and 4600 Chemistry Systems and the VITROS 5600 Integrated System. Multiple lots affected, with expiry dates through 22-Mar-2015 Class II Ortho Clinical Diagnostics is recalling Slide Dispense cartridges used with some VITROS Chemistry Product Slides due to slide dispense issues. Ortho-Clinical Diagnostics
Devices VITROS Chemistry Products THEO Slides packaged as 300 slides/pack catalog number 8301764 and packaged as 90 slides/pack catalog number 1307164 VITROS THEO Slides quantitatively measure theophylline (THEO) concentration in serum and plasma using VITROS 250/350/950/5,1 FS and 4600 Chemistry Systems and the VITROS 5600 Integrated System. Multiple lots affected, with expiry dates through 22-Mar-2015 Class II Ortho Clinical Diagnostics is recalling Slide Dispense cartridges used with some VITROS Chemistry Product Slides due to slide dispense issues. Ortho-Clinical Diagnostics
Devices VITROS Chemistry Products TRIG Slides packaged as 300 slides/pack catalog number 1336544 and packaged as 90 slides/pack catalog number 8329930 VITROS TRIG Slides quantitatively measure triglyceride (TRIG) concentration in serum and plasma using VITROS 250/350/950/5,1 FS and 4600 Chemistry Systems and the VITROS 5600 Integrated System. Multiple lots affected, with expiry dates through 22-Mar-2015 Class II Ortho Clinical Diagnostics is recalling Slide Dispense cartridges used with some VITROS Chemistry Product Slides due to slide dispense issues. Ortho-Clinical Diagnostics
Devices VITROS Chemistry Products UPRO Slides packaged as 90 slides/pack catalog number 6800120 VITROS UPRO Slides quantitatively measure protein (UPRO) concentration in urine using VITROS 250/350/950/5,1 FS and 4600 Chemistry Systems and the VITROS 5600 Integrated System. Multiple lots affected, with expiry dates through 22-Mar-2015 Class II Ortho Clinical Diagnostics is recalling Slide Dispense cartridges used with some VITROS Chemistry Product Slides due to slide dispense issues. Ortho-Clinical Diagnostics
Devices VITROS Chemistry Products URIC Slides packaged as 300 slides/pack catalog number 1943927 VITROS URIC Slides quantitatively measure uric acid (URIC) concentration in serum, plasma, and urine using VITROS 250/350/950/5,1 FS and 4600 Chemistry Systems and the VITROS 5600 Integrated System. Multiple lots affected, with expiry dates through 22-Mar-2015 Class II Ortho Clinical Diagnostics is recalling Slide Dispense cartridges used with some VITROS Chemistry Product Slides due to slide dispense issues. Ortho-Clinical Diagnostics
Devices Polyglycolic-Lactic Acid Absorbable Surgical Suture Label reads in part "Coated VILET *** (Polyglacin 910) Suture UNDYED BRANDED V423 *** Riverpoint ***" PGLA surgical suture is indicated for use in general soft tissue approximation and/or ligation, including use in opthalmic procedures, but not for use in cardiovascular and neurological tissues Lot 120716-01 Class II Riverpoint Medical is recalling PGLA Surgical Suture (Vilet) because the label indicates the suture is undyed and it is actually a violet colored suture. Riverpoint Medical, LLC
Biologics Red Blood Cells Leukocytes Reduced W128712017309 Class II Blood product, collected from a donor who reported travel through a malarial endemic area, was distributed. Delta Blood Bank
Biologics Red Blood Cells W286812082842 Class II Blood products, collected from a donor who traveled to a malarial endemic area, were distributed. LifeSource
Biologics Platelets W286812082842 Class II Blood products, collected from a donor who traveled to a malarial endemic area, were distributed. LifeSource
Biologics Platelets Pheresis Leukocytes Reduced W04381330216; W04381330216; W043813300576; W043813300576; W043813300766 Class II Blood products, collected from a donor who traveled to a malarial endemic area, were distributed. LifeShare Community Blood Services
Biologics Red Blood Cells Leukocytes Reduced 5033025 Class II Blood product, collected from a donor who was previously deferred, was distributed. Community Blood Center, Inc.
Food Mixed nuts in a plastic bag labeled in part: PREMIUM QUALITY; Terri Lynn Inc.; Deluxe Mixed; No Peanuts; NET WT. 16 OZ. (1 LB.) 454 g; P.O. BOX 5118 ELGIN, IL 60121 Item Number: 60025; Julian Code: 3180; Lot Number: MO-00551270 Class I Terri Lynn Inc. "Deluxe Mixed Nuts No Peanuts" was found to have undeclared peanuts inside the bag. Terri Lynn Inc.
Food Mixed nuts in a plastic bag labeled in part: Deluxe Mixed Nuts with Macadamia; NET WT. 12 OZ. (340 g), 30 LB, 35 LB; P.O. BOX 5118 ELGIN, IL 60121 12-oz.: Item Number: 09720; Best Buy Date: 12-29-14; Lot Number: MO-0551140; 30-lb: Item Number: 20062; Julian Code: 3203; Lot Number: MO-00554485; 35-lb: Item Number: 96004; Lot Number: MO-00550823 Class I Terri Lynn Inc. "Deluxe Mixed Nuts No Peanuts" was found to have undeclared peanuts inside the bag. Terri Lynn Inc.
Biologics Red Blood Cells Leukocytes Reduced W270113503891 Class III Blood products, collected from a donor who previously tested positive for NAT, were distributed. Central Pennsylvania Blood Bank
Biologics Fresh Frozen Plasma W270113503891 Class III Blood products, collected from a donor who previously tested positive for NAT, were distributed. Central Pennsylvania Blood Bank
Biologics Platelets Pheresis Leukocytes Reduced W051513080504 Class II Platelet, with insufficient plasma volume to support the platelet yield, was distributed. Innovative Blood Resources
Biologics Red Blood Cells 1683440 Class II Blood products, collected from a donor for whom donor suitability was not adequately determined, were distributed. OneBlood, Inc.
Biologics Fresh Frozen Plasma 1683440 Class II Blood products, collected from a donor for whom donor suitability was not adequately determined, were distributed. OneBlood, Inc.
Biologics Red Blood Cells (Apheresis) Leukocytes Reduced 2129638; 2129638; 2453096; 2453096 Class II Blood products, collected from a donor for whom donor suitability was not adequately determined, were distributed. OneBlood, Inc.
Devices Medcare Products Max-500 Stand, Total Support, patient stand, model #400006. The responsible firm name listed in the Operations Manual is Medcare Products, Burnsville, MN. Used for assisting patients/residents to a standing position. Serial numbers 0109STH0042, 0112STH0085, 0112STH0086, 0112STH0087, 0112STH0089, 0112STH0090, 0112STH0091, 0112STH0092, 1211STH0071, 0207STH0003, 0207STH0004, 0209STH0043, 0211STH0072, 0212STH0093, 0212STH0094, 0212STH0095, 0212STH0096, 0212STH0097, 0212STH0098, 0212STH0099, 0212STH0100, 0308STH0027, 0308STH0028, 0308STH0029, 0308STH0030, 0309STH0044, 0309STH0045, 0309STH0046, 0407STH0005, 0409STH0047, 0507STH0006, 0508STH0031, 0508STH0032, 0510STH0058, 0510STH0059, 0510STH0060, 0511STH0073, 0511STH0074, 0607STH0007, 0608STH0033, 0608STH0034, 0609STH0049, 0610STH0061, 0610STH0062, 0610STH0063, 0610STH0064, 0611STH0075, 0611STH0076,  ...
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Class II The lift might fail with the labeled 500-lb. load rating. Ergosafe Products LLC DBA Prism Medical Services USA
Devices Medcare Products Max-500 Stand-N-Weigh, Total Support, patient stand, model #400007. The responsible firm name listed in the Operations Manual is Medcare Products, Burnsville, MN. Used for assisting patients/residents to a standing position. Serial numbers 0106SWH0008, 0106SWH0009, 0106SWH0010, 0107SWH0031, 0107SWH0032, 0107SWH0033, 0107SWH0034, 0108SWH0044, 0108SWH0045, 0109SWH0065, 0109SWH0066, 0109SWH0067, 0109SWH0068, 0109SWH0069, 0109SWH0070, 0109SWH0071, 0111SWH0148, 0111SWH0149, 0111SWH0150, 0111SWH0151, 0112SWH0199, 0112SWH0200, 0112SWH0201, 0112SWH0202, 0112SWH0203, 0112SWH0204, 0206SWH0011, 0206SWH0012, 0209SWH0072, 0209SWH0073, 0209SWH0074, 0209SWH0075, 0209SWH0076, 0209SWH0077, 0209SWH0078, 0209SWH0079, 0211SWH0152, 0211SWH0153, 0211SWH0154, 0211SWH0155, 0211SWH0156, 0212SWH0210, 0212SWH0205, 0212SWH0206, 0212SWH0207, 0212SWH0208, 0212SWH0209, 0307SWH0035,  ...
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Class II The lift might fail with the labeled 500-lb. load rating. Ergosafe Products LLC DBA Prism Medical Services USA
Devices ADVIA 1200 System Software: 1) V2.00, 2) V2.01. Performs assays for general and specialty chemistries, methods for specific protein measurement, drugs-of-abuse testing and therapeutic drug monitoring. Product Codes: 1) 10386841, 2) 10469445 Class II Siemens Healthcare Diagnostics issued a Urgent Medical Device Correction due to Ration Parameters Flagging Behavior for All Software Versions utilized on ADVIA 1200, 1650, 1800 or 2400 Chemistry Systems. Siemens Healthcare Diagnostics
Devices ADVIA 1650 System Software: 1) V4.01, 2) V3.52. Performs assays for general and specialty chemistries, methods for specific protein measurement, drugs-of-abuse testing and therapeutic drug monitoring. Product Codes: 1) 10318424, 2) 10285281 Class II Siemens Healthcare Diagnostics issued a Urgent Medical Device Correction due to Ration Parameters Flagging Behavior for All Software Versions utilized on ADVIA 1200, 1650, 1800 or 2400 Chemistry Systems. Siemens Healthcare Diagnostics
Devices ADVIA 1800 System Software V2.01. Performs assays for general and specialty chemistries, methods for specific protein measurement, drugs-of-abuse testing and therapeutic drug monitoring. Product Code: 10639244 Class II Siemens Healthcare Diagnostics issued a Urgent Medical Device Correction due to Ration Parameters Flagging Behavior for All Software Versions utilized on ADVIA 1200, 1650, 1800 or 2400 Chemistry Systems. Siemens Healthcare Diagnostics
Devices ADVIA 2400 System Software V4.01. Performs assays for general and specialty chemistries, methods for specific protein measurement, drugs-of-abuse testing and therapeutic drug monitoring. Product Code: 10639265 Class II Siemens Healthcare Diagnostics issued a Urgent Medical Device Correction due to Ration Parameters Flagging Behavior for All Software Versions utilized on ADVIA 1200, 1650, 1800 or 2400 Chemistry Systems. Siemens Healthcare Diagnostics
Biologics Red Blood Cells Leukocytes Reduced W056313000110; Class II Blood product, collected from a donor who received a body piercing within 12 months of donating, was distributed. St Mary's Hospital and Medical Center, Inc.
Biologics Red Blood Cells Leukocytes Reduced W044213852164 Class III Blood product, collected from a donor with no documentation of an arm inspection, was distributed. San Diego Blood Bank
Biologics Red Blood Cells (Apheresis) Leukocytes Reduced 017GW71663; 017GW71665 Class II Blood products, possibly contaminated with air, were distributed. American National Red Cross (The) - North Central Region
Biologics Red Blood Cells (Apheresis) Leukocytes Reduced Irradiated 04GN24339; Class II Blood product, incorrectly identified as Jka negative, was distributed. The Aroostook Medical Center Blood Bank
Biologics Platelets Pheresis Leukocytes Reduced W040813600738; Class II Blood product, with no documentation of QC testing for platelet pH, was distributed. West Tennessee Regional Blood Center Inc
Biologics Red Blood Cells Leukocytes Reduced W038113113780; W038113030324; W038112382541; W038112214833; W038112185233; Class II Blood products collected from a therapeutic donor with polycythemia, were distributed. OneBlood, Inc.
Drugs Aldactone (spironolactone) tablets, USP, 100 mg, 100-count bottles, Rx only, Distributed by G.D. Searle, Division of Pfizer Inc, NY, NY 10017, NDC 0025-1031-31 V121573, Exp 05/17 Class II Marketed without an Approved NDA/ANDA: This recall is being initiated because of changes to the dissolution profile in distributed lots resulting from a manufacturing site change. There is currently no approved application supporting the alternate manufacturing site. Pfizer Us Pharmaceutical Group
Biologics Red Blood Cells Leukocytes Reduced W069113123942; W069112129934; Class II Blood products, collected from donors whose suitability to donate was not adequately determined, were distributed. Mississippi Blood Services Inc.
Biologics Blood and Blood Products for Reprocessing W069113123942; W069112129934; Class III Blood products, collected from donors whose suitability to donate was not adequately determined, were distributed. Mississippi Blood Services Inc.
Devices Model FL14E Rose BedsThe Rose Bed is an AC-powered adjustable long-term care bed intended for medical purposes that consists of a bed with a built-in motor and controls that can be operated to adjust the height and surface contour of the bed. The device includes movable and latchable siderails Model FL14E B01008 B05307 B08323 B11351 B14383 B17357 B20142 B23142 B01010 B05308 B08324 B11352 B14384 B17358 B20143 B23143 B01022 B05309 B08325 B11353 B14385 B17358 B20144 B23144 B01045 B05310 B08326 B11354 B14386 B17359 B20145 B23145 B01045 B05311 B08327 B11355 B14387 B17359 B20146 B23146 B01323 B05312 B08328 B11356 B14388 B17360 B20147 B23147  ...
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Class II It was reported that the siderail may appear latched when it is not, due to lack of proper preventive maintenance. This might result in bruises and/or lacerations to a patient who is leaning against the siderails if the siderail releases. Additionally, the siderail may not effectively constrain a patient to prevent them from rolling or falling off the bed. Stryker Medical Division of Stryker Corporation
Biologics Cryoprecipitated AHF W068513001326; Class II Blood products, collected from a donor considered to be at increased risk for Creutzfeldt-Jakob Disease (CJD), were distributed. Inland Northwest Blood Center
Biologics Blood and Blood Products for Reprocessing W068513001326; Class II Blood products, collected from a donor considered to be at increased risk for Creutzfeldt-Jakob Disease (CJD), were distributed. Inland Northwest Blood Center
Biologics Blood and Blood Products for Reprocessing 011GC03860; Class III Blood product, collected from a donor whose suitability to donate was not adequately determined, was distributed. American Red Cross Blood Services
Drugs Omeprazole Delayed-Release Capsules, USP, 20 mg, Rx Only, 1000 Capsules per bottle, Distributed by: Kremers Urban Pharmaceuticals Inc. Princeton, NJ 08540, USA, NDC: 62175-118-43 Lot Number 59627; Expiration Date 02/2014 Class II Failed Tablet/Capsule Specification: some capsules over time do not meet or are suspected to not meet the specification for acid resistance. Kremers Urban Pharmaceuticals, Inc.
Devices *** 1) SYMBIQ One-Channel Infuser; *** 2) SYMBIQ Two-Channel Infuser; *** E09 batteries can be identified by the "E09" that is printed beneath the bar code and at the end of the serial number along the bottom of the label found on each battery; *** E10 batteries can be identified by the "E10" that is printed beneath the bar code and at the end of the serial number along the bottom of the label found on each battery. Symbiq is a general-purpose infuser designed to deliver fluids, solutions, medications, agents, nutritionals, electrolytes, blood and blood products for parenteral, enteral, intra-arterial, subcutaneous, or irrigation routes of administration. *** 1) SYMBIQ One-Channel Infuser, List Number: 16026-04-01/02/03/04/25/26/43/44/45/46/51/52/53/54/55/56/57/58/65/66/69/70/77/78/79/80/81/82/83/84/87/88/89/90/93/94; *** 2) SYMBIQ Two- Channel Infuser, List Number: 16027-04-01/02/03/04/25/26/43/44/45/46/51/52/53/54/55/56/57/58/65/66/69/70/77/78/79/80/81/82/83/84/87/88/89/90/ 93/94; *** X) Battery Pack E10 Part Number: HSP3566-E10; *** X) Battery Pack E09 Part Number: HSP3566-E09 Class II Hospira shipped the incorrect replaceable battery pack (Part No: HSP3566-E10) instead of the correct E09 battery pack (Part No. HSP3566-E09) for the Symbiq Single and Dual Channel Infusers. Hospira Inc.
Drugs Oxcarbazepine Oral Suspension, 300 mg/5 mL, 250 mL bottle, Rx only, Boehringer Ingelheim, Roxane Laboratories, Inc. Columbus, Ohio 43216, NDC 0054-0199-59 Lot # 161304B, Exp. OCT 2013 Class II Resuspension Problems: Recalled lot did not meet resuspendability requirements. Boehringer Ingelheim Roxane Inc
Devices BIOMET Spine, Parsippany, NJ 07054. 5.5 TI 5.5x50mm Translation Screw Polaris 5.5 TI Spinal System. Rx Only. Non-Sterile. Intended for immobilization and stabilization as an adjunct to fusion as a pedicle screw fixation system Multiple Item and Lot numbers. Class II Polaris Translation Screw Failures were recently reported to Biomet Spine. These failures are generally described as dissociation of the screw head from the shaft of the Polaris Translation Screw. Ebi, Llc
Food Idahoan, Steakhouse Parmesan topping, Net Weight 35 lbs., Item Code ZID800Bulk. Lot 3239 Class II Steakhouse Parmmesan Topping was produced on the same equipment line as another product that tested positive for Salmonella. Kerry Foods
Devices ExciTE F DSC Soft touch Single Dose, Dual-curing Regular Ref. 50 dental adhesive for restorations Product Code 630378AN; Lot Number: R59595; Expiration date of 3 January 2015 Class II Ivoclar Vivadent, Inc. is recalling a lot of ExciTE F DSC Dental Adhesive found to produce a blue green discoloration when used in combination with cements. Ivoclar Vivadent, Inc.
Drugs Derma-Smoothe/FS (fluocinolone acetonide) 0.01% Topical Oil (Scalp Oil), 118.28 mL (4 Fl. oz.) bottle, Rx only, Manufactured and Distributed by: Hill Dermaceuticals, Inc., Sanford, Florida 32773, NDC 28105-149-04. K111090 exp.10/13, K111122 exp10/13, K111140 exp.10/13, K111150 exp.10/13, 111180 exp.11/13, L111190 exp11/13, M111250 exp.12/13, M111270 exp.12/13, and M111292 exp.12/13 Class III Subpotent Drug: The active ingredient, fluocinolone acetonide, was found to be subpotent during the firm's routine testing. Hill Dermaceuticals, Inc.
Drugs Derma-Smoothe/FS (fluocinolone acetonide) 0.01% Topical Oil (Body Oil), 118.28 mL (4 fl. oz.) bottle, Rx only, Manufactured and Distributed by: Hill Dermaceuticals, Inc., Sanford, Florida 32773, NDC 28105-150-04. K111100 exp.10/13, K111110 exp.10/13, M111240 exp.12/13, and A120012 exp.01/14 Class III Subpotent Drug: The active ingredient, fluocinolone acetonide, was found to be subpotent during the firm's routine testing. Hill Dermaceuticals, Inc.
Food Multi Complete (Full Strength Mini and Multi Softgels), 60 Count Bottle. 24 units per master case.+++Multi Complete (club size) (Full Strength Mini and Multi Softgels), 180 Count Bottle. 20 units per master case. Product labeling reads in part:"NatureMade***DIETARY SUPPLEMENT 60 SOFTGELS***Distributed by: Nature Made Nutritional Products Mission Hills, CA 91346-9606, U.S.A 1-800-276-2878 www.NatureMade.com***" All Lots. UPC Code 0-31604-02861-9, List # 2861. +++ All lots. UPC Code 2874 0-31604-02874-9. List # 2874. Class II Pharmavite LLC is conducting a voluntary recall of all lots of its Nature Made Full Strength Mini Multivitamins (recently repackaged as "Multi" softgels, (Multi Complete, Multi for Her, Multi for Her 50+, Multi for Him, Multi Complete club size). because recent quality tests indicate that the Vitamins B1 and B12 are losing potency more rapidly than initially expected, and these products are not meeting label claims for these vitamins throughout their shelf life. Pharmavite Corporation
Food Multi for Her (Full Strength Mini and Multi Softgels), 60 Count Bottle. 24 units per master case. Product labeling reads in part:"NatureMade***DIETARY SUPPLEMENT 60 SOFTGELS***Distributed by: Nature Made Nutritional Products Mission Hills, CA 91346-9606, U.S.A 1-800-276-2878 www.NatureMade.com***" All lots. UPC Code 2862 0-31604-02862-6. List # 2862. Class II Pharmavite LLC is conducting a voluntary recall of all lots of its Nature Made Full Strength Mini Multivitamins (recently repackaged as "Multi" softgels, (Multi Complete, Multi for Her, Multi for Her 50+, Multi for Him, Multi Complete club size). because recent quality tests indicate that the Vitamins B1 and B12 are losing potency more rapidly than initially expected, and these products are not meeting label claims for these vitamins throughout their shelf life. Pharmavite Corporation
Food Multi for Her 50+ (Full Strength Mini and Multi softgels) 24 units per master case. Product labeling reads in part:"NatureMade***DIETARY SUPPLEMENT 60 SOFTGELS***Distributed by: Nature Made Nutritional Products Mission Hills, CA 91346-9606, U.S.A 1-800-276-2878 www.NatureMade.com***" All lots. UPC Code 2863 0-31604-02863-3. List # 2863. Class II Pharmavite LLC is conducting a voluntary recall of all lots of its Nature Made Full Strength Mini Multivitamins (recently repackaged as "Multi" softgels, (Multi Complete, Multi for Her, Multi for Her 50+, Multi for Him, Multi Complete club size). because recent quality tests indicate that the Vitamins B1 and B12 are losing potency more rapidly than initially expected, and these products are not meeting label claims for these vitamins throughout their shelf life. Pharmavite Corporation
Food Multi For Him (Full Strength Mini and Multi Softgels), 60 Count Bottle. 24 units per master case. Product labeling reads in part:"NatureMade***DIETARY SUPPLEMENT 60 SOFTGELS***Distributed by: Nature Made Nutritional Products Mission Hills, CA 91346-9606, U.S.A 1-800-276-2878 www.NatureMade.com***" All lots. UPC Code 2864 0-31604-02864-0. List # 2864. Class II Pharmavite LLC is conducting a voluntary recall of all lots of its Nature Made Full Strength Mini Multivitamins (recently repackaged as "Multi" softgels, (Multi Complete, Multi for Her, Multi for Her 50+, Multi for Him, Multi Complete club size). because recent quality tests indicate that the Vitamins B1 and B12 are losing potency more rapidly than initially expected, and these products are not meeting label claims for these vitamins throughout their shelf life. Pharmavite Corporation
Devices Ready to Use Thymo-Cide, Germicidal Detergent, containing 0.051% thymol, packaged in 1-qt. bottles. The firm name on the label is Wexford Labs, Inc., Kirkwood, MO. For disinfection of hard, non-porous surfaces (floors, walls, tables, etc.) in operating rooms, intensive care, nurseries, emergency areas, dental operatories, police, EMS, and all health care facilities. Lot numbers 091721, exp. 10/13; 101521, exp. 11/13; 0109131, exp. 2/14; 0215131, exp. 3/14; 0320131, exp. 4/14; 0415132, exp. 5/14; 0516131, exp. 6/14; and 0624131, 7/14. Class II Expired active ingredient was used in the manufacture of the product. Wexford Labs Inc
Devices Siemens Chemistry Calibrator (CAL) used with the ADVIA Chemistry Direct Bilirubin_2 Reagent, Siemens Material Number (SMN) 10312279, REF 09784096, Part Number T03-1291-62; IVD Product usage: Usage: DBIL_2: For in vitro diagnostic use in the quantitative determination of direct bilirubin in human serum and plasma on the ADVIA Chemistry systems. Such measurements are useful in the screening of liver function disorders or in the diagnosis of jaundice. Lots 090445B (exp. 07/2014) and 090445C (exp. 10/2014) Class II Siemens Healthcare Diagnostics is conducting a field correction for Siemens Chemistry Calibrator Lots 090445B and 090445C on the ADVIA 1200, 1650, 1800, and 2400 Chemistry Systems. The System Specific Values (SSVs) for the Direct Bilirubin Assay (DBIL_2) have been reassigned for these lots. Siemens has determined that the DBIL_2 SSVs currently assigned to these lots may cause an average shift of +7-9 % in quality control and sample recovery at a level of 3 mg/dL. This Urgent Medical Device Correction provides reassigned values for the DBIL_2 SSVs for Chemistry Calibrator Lots 090445B and 090445C. Siemens Healthcare Diagnostics
Drugs Metoclopramide Injection, USP 10 mg (5mg/mL), 2 mL Single-dose Vial, Rx Only, Sterile, Hospira Inc., Lake Forest, IL, 60045, USA, NDC 0409-3414-01 Lot #: 28-104-DK*, Exp 10/01/2014 (* lot number may be proceeded with an 01) Class II Presence of Particulate Matter: Potential vendor glass issue - glass spiticules (glass strands) were identified during site inspection of the vials. Hospira Inc.
Drugs Ondansetron Injection, USP, 4 mg/2 mL (2 mg/mL), 2 mL Single-dose Vial, Rx Only, Sterile, Hospira Inc., Lake Forest IL 60045, USA, NDC 0409-4755-03 29-484-DK* and 29-510-DK* Exp 05/01/2015 (lot number may be proceeded with an 01) Class II Presence of Particular Matter: Potential vendor glass issue - glass spiticules (glass strands) were identified during site inspection of the vials. Hospira Inc.
Veterinary Agway LS Meat Goat 16 PL (DQ) (AX) MEDICATED, Net Wt. 50 lb poly bags Product Code 200593, Lot #AX3242 Class II Cargill Feed & Nutrition has recalled Agway LS Meat Goat 16 Pellet with Decox due to the presence of excessive amounts of selenium. Cargill Inc.
Devices Trinica Anterior Lumbar Plate (ALP) system, part 07.01058.001. Non Sterile, Rx only. The Trinica Anterior Lumbar Plate System is a temporary supplemental fixation device consisting of a variety of shapes and sizes of plates and screws. The Trinica Anterior Lumbar Plate System is used as an implant for the correction and stabilization of the spine. This system provides temporary stabilization and augments the development of a solid spinal fusion. Additionally, this system provides the surgeon with the ability to supplement an interbody device with anterior plate fixation. The Trinica Anterior Lumbar Plate System components can be locked into a variety of configurations and each construct may be customized to individual cases. The plates are low profile and anatomically designed to provide optimal fit from either anterior or anterior-lateral approach. This system also features anti-migration locking caps to help secure the fixation screws. All Trinica Anterior Lumbar Plate System implant components are made from titanium alloy (Ti-6AI-4V). The Trinica Anterior Lumbar Plate System is indicated for use via the lateral or anterolateral surgical approach above the bifurcation of the great vessels or via the anterior surgical approach, below the bifurcation of the great vessels. This system is indicated in the treatment of lumbar or lumbosacral (L1-SI) spine instability as a result of fracture (including dislocation and subluxation), tumor, degenerative disc disease (defined as back pain of discogenic origin with degeneration of the disc confirmed by history and radiographic studies), pseudoarthrosis, spondylolisthesis, scoliosis, lordotic deformities of the spine, spinal stenosis, or a failed previous fusion. Lots: P060509, P061255, P070617, P080422, P090046 Class II Zimmer Spine, Inc. is initiating a correction regarding the Trinica ALP Instrument Tray, part 07.01058.001 (all lots). The Ratchet Handles, part 07.00438.001 may not be effectively sterilized if left in their designated location(s) in the instrument tray. This is due to the current bracketing in the tray potentially interfering with complete steam penetration into the cannulated handle. Zimmer, Inc.
Devices GE Vivid E9 ultrasound system. GE Vivid E9 is a Track 3 diagnostic ultrasound system, which is primarily intended for cardiac imaging and analysis, but which also includes vascular and general radiology applications. The Vivid E9 incorporates a variety of electronic array transducers operating in linear, curved linear, sector/phased array or matrix array format, including two dedicated CW transducers and several real time 3D transducers. It consists of a mobile console with keyboard control panel; color LCD/TFT touch panel, LCD color video display and optional image storage and printing devices. It provides high performance ultrasound imaging and analysis and has comprehensive networking and DICOM capability. Serial numbers: 0000000VE94166, 0000000VE94167, 0000000VE94170, 0000000VE94171, 0000000VE94172, 0000000VE94173, 0000000VE94174, 0000000VE94175, 0000000VE94176, 0000000VE94177, 0000000VE94178, 0000000VE94179, 0000000VE94180, 0000000VE94181, 0000000VE94182, 0000000VE94183, 0000000VE94184, 0000000VE94185, 0000000VE94186, 0000000VE94187, 0000000VE94188, 0000000VE94190, 0000000VE94191, 0000000VE94192, 0000000VE94193, 0000000VE94194, 0000000VE94195, 0000000VE94196, 0000000VE94197, 0000000VE94198, 0000000VE94199, 0000000VE94210, 0000000VE94211, 0000000VE94212, 0000000VE94213, 0000000VE94214, 0000000VE94215, 0000000VE94216, 0000000VE94217, 0000000VE94225, 0000000VE94226, 0000000VE94227, 0000000VE94231, 0000000VE94232, 0000000VE94233, 0000000VE94234, 0000000VE94235, 0000000VE94236,  ...
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Class II GE became aware of a potential safety issue due to a system slow down and system lock up associated with the software of Vivid E9 ultrasound system. During a critical procedure the Vivid E9 Scanner may gradually become unresponsive and eventually lock up, with the result that the vivid E9 Scanner must be rebooted. GE Healthcare, LLC
Food Good Sense Spicy Sweet Mix, 25-oz (1lb 9oz) plastic container, UPC: 030243787178 Lot 09/06/14 Class II Krispak, Inc. is voluntarily recalling one lot of Spicy Sweet Mix due to a potential mislabeling, resulting in undeclared allergens. Good Sense City Mix (contains: Peanut, Milk, Almond, Cashew, Soy) was labeled as Good Sense Spicy Sweet Mix (contains: Peanut, Milk, Wheat, Soy), resulting in the undeclared allergens of Almond and Cashew. Krispak Inc
Devices Synthes Soft Tissue Retractor Small Extendible Offset blade facilitates easy preparation of the epipereosteal cavity for percutaneous plate insertion. Part # Lot # 325.01 1776332 325.01 1834589 325.01 1855361 325.01 1893067 325.01 1903596 325.01 1952258 325.01 1986932 325.01 3067805 325.01 3150691 325.01 3179456 325.01 3186865 325.01 3220973 325.01 3241083 325.01 3268079 325.01 3360992 325.01 3719234 325.01 3818913 325.01 4948929 325.01 4994679 325.01 4994680 325.01 5031083 325.01 5031085 325.01 5391773 325.01 5420979 325.01 5420980 325.01 5476369 325.01 5476370 325.01 5510070 325.01 5544585 325.01 5546329 325.01 5563699 325.01 5569041 325.01 5624246 325.01 5657366 325.01 5677289 325.01 5759764 325.01 5759765 325.01 5779363 325.01 7698954 325.01 7826103 Class II The potential exists for the locking screw nut to break on the Soft Tissue Retractor if it is overt-tightened. Synthes USA HQ, Inc.
Devices Aesculap Arcadius XP L Trial Insertion Instrument (ME020R/ME020R-US) model no. ME020R Class II The trial insertion instrument may disassemble during use due to a potentially weak weld on then trial inserter shaft block area located near the thumb wheel. Aesculap, Inc.
Food Cellulase Enzyme Blends, bulk, custom blended formulations identified as Cellulase BX and Celluase Conc, packed in boxes or drums ranging from 1 kg to 25 kg, item # CELIND, labeled in part ***Manufactured by BIO-CAT, INC.9117 Three Notch Road Troy, Virginia 22974 Telephone (800) 545-9052 Fax (434) 589-3301 E-mail: info@bio-cat.com Website: www.bio-cat.com*** Lots: fsb-tw07 fsb-uw14 fsb-vw08 pob-tw31 pob-vw27 pob-xw23 pob-aw05 cbx-yw12 cbx-xw06 cbx-xw10 cbx-aw09 ccu-yw06 Class II Raw material enzymes intended for further manufacturing of foods and dietary spplements may be contaminated with chloramphenicol. Bio-Cat Inc
Food Pectinase Enzyme Blends, bulk, custom blended formulations identified as pectinase 500, pectinase 1000, Pectinase 350 Endo-pg/gm, PC Blend 14, Nut 14-500, pectinase 3500, gastro blend 0111, Digestive Blend 021894, enzyme complex 5763, pectinase 1750, pectinase 350, EC-CHPX, enzyme blend for cyto grn, pectinase 150m, and Cellulase 3, packed in boxes or drums ranging from 1 kg to 25 kg, item # PECCI, labeled in part ***Manufactured by BIO-CAT, INC.9117 Three Notch Road Troy, Virginia 22974 Telephone (800) 545-9052 Fax (434) 589-3301 E-mail: info@bio-cat.com Website: www.bio-cat.com*** Lots: SYNAE-VW18 SYNAE-VW19 SYNAE-VW20 BRI-XW16 E7X-TW03 E7X-UW20 E7XBY-UW21 E7X-WW26 E7XBY-XY07 E7X-YW25 E7X-ZW24 E7X-BW16 PE003-UW21 PE003-XW02 EBY2X-UW22 EBW-VW12 EBW-VW13 EBW-VW14 EBW-XW10 EBW-XW13 EBW-XW14 EBY2X-XW15 EBW-YW11 EBW-YW12 EBW-YW13 EBW-AW19 EBW-AW20 PE350-VW01 PE350-YW19 EBW-AW21 pe05-ww30 ALI13249-03 ali13024-02 ali13036-01 ali13212-04 ali13157-09 bgb0111-vw26 db18-xw24 db18-yw04 db18-yw06 db18-aw22 DB18-ZW23 DB18-AW30 ec5763-bw06 pe035-tw23 peo35-tw14 pe1750-vw11 pe350-vw11 ECHPX-ZW18 pe350-xw22 pe350-aw13 ebcyto-yw28 ebcyto-aw09 ebcyto-bw19 pe150-vw20 pe150-bw05 cell3-ww18 cell3-xw07 cell3-aw01 cell3-AW14 pe01-uw07 pe035-yw07 EB7-XW08 EB7-AW23 Class II Raw material enzymes intended for further manufacturing of foods and dietary spplements may be contaminated with chloramphenicol. Bio-Cat Inc
Food Xylanase Enzyme Blends, bulk, custom blended formulations identified as xylanase 1000, xylanase 150,000 XU, synerzyme-ae, brizyme, Cellulase Special Blend OMRI, xylanase amylase blend, Bio-Cat Ruminant Enzyme, Feed Blend ws alkacel 20x, BC-XR, enzyme blend #2237, CHX blend, EB-7 multi-enzyme blend EB110311-01, EB020812-01, xylanase 70,000, nut 14-500, ultra blend 102 xylanase 10,000, bb cd blend #3, soy blend, amiron blend, Formula #121412b, erc530b, pn digestive blend, digest basic, blend 0313, xylanase 20,000, EC-CHPX, Xylanase 50,000 XU, Xylanase 50m XU, Xylanase 25,000, Xylanase 190,000 XU, af-5x, silage blend, xylanase concentrate, Enzyme Blend 1, and Enzyme Blend 2, packed in boxes or drums ranging from 1 kg to 25 kg, item # XYXP, labeled in part ***Manufactured by BIO-CAT, INC.9117 Three Notch Road Troy, Virginia 22974 Telephone (800) 545-9052 Fax (434) 589-3301 E-mail: info@bio-cat.com Website: www.bio-cat.com*** Lots: xy150-vw08 synae-vw18 synae-vw19 synae-vw20 xy150-tw14 bri-xw16 xy150-tw22 xy150-yw05 csbomri-xw20 xab-vw21 xab-aw07 bcr-yw14 bcr-aw05 fbws-uw04 fbws-aw02 alc20-ww05 xy150-xw30 bcxr-tw04 bcxr-ww12-a (375)/bcxr-ww12-b (125) bcxr-yw27 bcxr-aw15 eb2237-vw14 chxb-uw27 xy150-zw17 xy150-tw15 xy150-uw21 xy150-xw02 xyc-yw06 xy150-uw26 ali13008-01 ali13008-02 ali13008-13 ali13036-01 ali13053-05 ali13071-01 ali13071-02 ali13140-02 ali13140-03 ali13200-08 ali13200-09 ali13212-04 ali13157-11 ali13206-05 ali13206-06 bbcdb-vw25 bbcdb-xw02 soyb-tw21 soyb-zw02 xy150-tw16 xy150-vw14 xy150-ww08 amib-uw06 amib-uw13 f121412b-vw13 erc530b-xw22 xy150-aw13 xy150-aw20 pndb-xw28 xy150-tw23 db-bw12 b0313-vw22 xy10-uw15 xy20-ww02 xy10-xw20 ecchpx-zw18 xy50-tw09 xy150-tw09 xy50-tw09 xy150-tw16 xy150-vw22 xy150-ww05 xy50-ww09 xy150-ww22 xy150-xw23 xy150-yw24 xy150-zw02 xy50-zw11 xy150-zw19 xy150-aw07 xy50-aw23 xy25-xw22 xy200-vw22 xy150-uw20 af5x-uw04 sb-xw09 xy150-uw08 xy01-vw11 xyc-ww24 xyc-ww18 eb1-yw03 eb2-yw03 Class II Raw material enzymes intended for further manufacturing of foods and dietary spplements may be contaminated with chloramphenicol. Bio-Cat Inc
Devices ALTRUS® THERMAL TISSUE FUSION, Tissue Fusion Handpiece, 5 mm O.D., 16 cm Shaft, REF 60-9520-001, STERILE -- CONMED CORPORATION 525 FRENCH RD, UTICA, NY 13502 --- The ConMed Altrus® Thermal Tissue Fusion System is comprised of a dedicated energy source and disposable handpiece used to ligate (seal) and divide (cut) blood vessels and tissue bundles that fit into the jaws of the handpiece. The Altrus® System utilizes a thermal energy platform to achieve the desired clinical effect. The ConMed Altrus® Thermal Tissue Fusion handpiece is a single use device which is provided sterile. The device uses scissors to parallel jaw closure mechanism with one flat jaw and one crowned jaw in which the vessels/tissues are grasped and through which pressure and heat are applied. It is a multi-functional device capable of vessel sealing, grasping and dissecting during open general surgical procedures. The two jaw sizes allow for applications in a variety of clinical environments for access in confined areas as well as large open areas. Lot 13CHB007 Class II The affected lots were exposed to a higher than acceptable level of particulate matter during manufacture and subsequently distributed. ConMed evaluated the potential risk that this issue could present to the patient and concluded the risk of injury to be negligible; however exposure could cause a minor, local, self correcting infection. ConMed Corporation
Devices ALTRUS® THERMAL TISSUE FUSION, Tissue Fusion Handpiece, 5 mm O.D., 36 cm Shaft, REF 60-9522-001, STERILE -- CONMED CORPORATION 525 FRENCH RD, UTICA, NY 13502 --- The ConMed Altrus® Thermal Tissue Fusion System is comprised of a dedicated energy source and disposable handpiece used to ligate (seal) and divide (cut) blood vessels and tissue bundles that fit into the jaws of the handpiece. The Altrus® System utilizes a thermal energy platform to achieve the desired clinical effect. The ConMed Altrus® Thermal Tissue Fusion handpiece is a single use device which is provided sterile. The device uses scissors to parallel jaw closure mechanism with one flat jaw and one crowned jaw in which the vessels/tissues are grasped and through which pressure and heat are applied. It is a multi-functional device capable of vessel sealing, grasping and dissecting during open general surgical procedures. The two jaw sizes allow for applications in a variety of clinical environments for access in confined areas as well as large open areas. Lot 13CHB006 Class II The affected lots were exposed to a higher than acceptable level of particulate matter during manufacture and subsequently distributed. ConMed evaluated the potential risk that this issue could present to the patient and concluded the risk of injury to be negligible; however exposure could cause a minor, local, self correcting infection. ConMed Corporation
Devices Synthes Titanium Trochanteric Fixation Nail (TFN)-Helical Blade Synthes Titanium Trochanteric Fixation Nail (TFN)-Helical Blade is used to treat stable and unstable fractures of the proximal femur including pertrochanteric fractures, intertrochanteric fractures, basal neck fractures, and combinations thereof. The long TFN is additionally indicated for subtrochanteric fractures, pertrochanteric fractures associated with shaft fractures, pathologic fractures (including prophylactic use) in both trochanteric and diaphyseal regions, long subtrochanteric fractures, proximal or distal non-unions, malunions, and revisions. part nos. 456.300-456.310 & 456.650, 456.300S-456.310S & 456.650S, with lot nos. 561864 through 7423581 Class II A potential exists for non conforming Synthes Titanium Trochanteric Fixation Nail (TFN)-Helical Blades to be distributed. Synthes USA HQ, Inc.
Devices Epsilon Skin Tensioner:Rx, Sterile Sterilized using Gamma. Turns Red if sterilized using Gamma; Product Usage: Skin Tensioner is applied to patients scalp during follicular harvesting during hair restoration procedure. Product applies tension to scalp to facilitate follicular extractions. Model number FP-45384 Class II Reports of discoloration (residue) on the pins of the skin tensioner have been received by several customers. Discoloration due to insufficient cleaning of stainless steel pins during passivation process. The residue has been identified as a compound of iron and chlorine. Restoration Robotics
Devices ARTAS Disposable Kit ( Contains Skin Tensioner FP-45384; Inner Needle with Vacuum Tube FP-45385; Dissection Punch 4.0mm FP-23304; Saline Nose Cone FP-45387; Follicle Trap - FP-23306 and Non-sterile Disposable Clinical Kit FP -23267): and ARTAS Disposable Kits, 18 Gauge Epsilon (Contains Disposable Kit, 18 Gauge Epsilon FP 45547 and Non-Sterile Disposable Kit FP-23267). RX. Product Usage: Skin Tensioner is applied to patients scalp during follicular harvesting during hair restoration procedure. Product applies tension to scalp to facilitate follicular extractions. Model number FP-45616 and FP45173 Class II Reports of discoloration (residue) on the pins of the skin tensioner have been received by several customers. Discoloration due to insufficient cleaning of stainless steel pins during passivation process. The residue has been identified as a compound of iron and chlorine. Restoration Robotics
Devices Sterile Disposable Kit ( Contains Skin Tensioner ASY-25067; Three Mark Needle Assembly ASY-25094; Nose Cone Assembly ASY-25098; Dissection 4 mm PRT-25117, follicle Trap PRT 23999): Product Usage: Skin Tensioner is applied to patients scalp during follicular harvesting during hair restoration procedure. Product applies tension to scalp to facilitate follicular extractions. Model number FP-45547 Class II Reports of discoloration (residue) on the pins of the skin tensioner have been received by several customers. Discoloration due to insufficient cleaning of stainless steel pins during passivation process. The residue has been identified as a compound of iron and chlorine. Restoration Robotics
Devices ARTAS Disposable and Reuseable Kit ( Contains Skin Tensioner FP-45384; Inner Needle with Vacuum Tube FP-45385; dissection Punch 4.0mm FP 23304; Saline Nose Cone FP-45387; Follicle Trap FP 23306; Non-Sterile Disposable kit FP 23267 and Molded Parts, Reusable Kit FP 45538 Rx): Product Usage: Skin Tensioner is applied to patients scalp during follicular harvesting during hair restoration procedure. Product applies tension to scalp to facilitate follicular extractions. Model number FP-45399 Class II Reports of discoloration (residue) on the pins of the skin tensioner have been received by several customers. Discoloration due to insufficient cleaning of stainless steel pins during passivation process. The residue has been identified as a compound of iron and chlorine. Restoration Robotics
Food Organic Chevre sold at Farmer's Market in plastic 6 oz tubs, vacuum-sealed with lid and label on top of tub, Sunny Pine Farm brand. Product also sold to in 2 lbs. and 3 lbs. to restaurant. Product is labeled in parts: "***Organic Goat Dairy***Chevre***SUNNY PINE FARM***6 oz***Pasteurized Organic Goat Milk, Salt, Rennet, and Culture***Keep refrigerated***Handcrafted in Twisp, Washington 98856***. Expiration dates of products sold to non-restaurant consignees: 10/16/2013. Expiration dates of products sold to restaurants: 10/23/13 and 11/5/13. Chevre cheese products sold at Methow Valley Farmers Market (aka Twisp Farmers Market) between 7/27/13 and 10/12/13 were NOT labeled with an expiration date. Class II Sunny Pine Farm of Twisp, Washington is voluntarily recalling Organic Chevre due to possible improper pasteurization. Sunny Pine Farm
Food Organic Parsley Chive Chevre sold to non-restaurant in plastic 6 oz plastic tub vacuum-sealed with lid and label on top of tub, Sunny Pine Farm brand. Product sold to restaurant is in 1 lb. and 2 lbs. size. The product is labeled in parts: "***Organic Goat Dairy***Parsley Chive Chevre***6 oz. ***SUNNY PINE FARM***Handcrafted in Twisp, Washington 98856***Pasteurized Organic Goat Milk, Salt, Parsley, Chives, Rennet, Cultures***Keep refrigerated***" Expiration dates of products sold to non-restaurant consignees: 10/16/2013. Expiration dates of products sold to restaurants: 10/23/13 and 11/5/13. Chevre cheese products sold at Methow Valley Farmers Market (aka Twisp Farmers Market) between 7/27/13 and 10/12/13 were NOT labeled with an expiration date. Class II Sunny Pine Farm of Twisp, Washington is voluntarily recalling Organic Parsley Chive Chevre due to possible improper pasteurization. Sunny Pine Farm
Food Organic Honey Lavender Chevre is sold in plastic 6 oz tubs under Sunny Pine Farm brand. The product is labeled in parts: "***Organic Goat Dairy***Honey Lavender Chevre***6 oz.***SUNNY PINE FARM***Handcrafted in Twisp, Washington 98856***Pasteurized Organic Goat Milk, Honey, Salt, Lavender, Rennet, Cultures***Keep refrigerated***". Expiration dates of products sold to non-restaurant consignees: 10/16/2013. Expiration dates of products sold to restaurants: 10/23/13 and 11/5/13. Chevre cheese products sold at Methow Valley Farmers Market (aka Twisp Farmers Market) between 7/27/13 and 10/12/13 were NOT labeled with an expiration date. Class II Sunny Pine Farm of Twisp, Washington is voluntarily recalling Organic Honey Lavender Chevre due to possible improper pasteurization. Sunny Pine Farm
Food Organic Black Pepper Garlic Chevre is sold in 3 lbs. vacuum plastic bag without labels since it sold to restaurants. However, the retail label is read in parts: "***Organic Goat Dairy***Black Pepper Garlic Chevre***6 oz***SUNNY PINE FARMS***Handcrafted in Twisp, Washington 98856***Pasteurized Organic Goat Milk, Garlic, Pepper, Salt, Rennet, and Cultures***Keep Refrigerated***". Expiration dates of products sold to restaurants: 10/23/13 and 11/5/13. Class II Sunny Pine Farm of Twisp, Washington is voluntarily recalling Organic Black Pepper Garlic Chevre due to possible improper pasteurization. Sunny Pine Farm
Devices Cougar® Nitinol Workhorse Guidewire: Models: CGRLS190HJ, CGRLS190HS, CGRLS190S, CGRLS300HS, CGRLS300S. CGRXT190HJ, CGRXT190HS, CGRXT190J, CGRXT190S, CGRXT300HJ, CGRXT300HS, CGRXT300J, CGRXT300S Medtronic guide wires are steerable guide wires that are used for the introduction and placement of diagnostics or interventional devices in the coronary and peripheral vasculature, and may be used to reach and cross a target lesion. Medtronic guide wires are not intended for cerebral vasculature. Medtronic steerable exchange guide wires are used to facilitate the substitution of one diagnostic or interventional device for another. G13A00104 G13A00105 G13A00106 G13A00107 G13A00108 G13A00109 G13A00110 G13A00112 G13A00113 G13A00114 G13A00692 G13A00713 G13A00734 G13A00788 G13A00803 G13A00804 G13A00809 G13A00810 G13A00811 G13A00874 G13A00971 G13A00972 G13A00973 G13A00974 G13A00975 G13A00976 G13A00977 G13A00978 G13A00979 G13A00980 G13A00981 G13A00982 G13A01016 G13A01017 G13A01330 G13A01400 G13A01401 G13A01409 G13A01410 G13A01411 G13A01446 G13A01449 G13A01452 G13A01569 G13A01584 G13A01600 G13A01604 G13A01605 G13A01606 G13A01607 G13A01608 G13A01609 GV827 GV829 GV830 GV831 GV832 GV835 GV836 GV837 GV838 GV839 GV840 GV844 GV845 GW405 GW406 GW407 GW508 GW509 GW510 GW675 GW687 GW688 GW706 GW710 GW745 GW746 Class I Potential for PTFE (polytetrafluroethylene) coating to delaminate and detach from Guidewire. Medtronic Vascular
Devices Zinger® Stainless Steel Workhorse Guidewire; Models: ZNGRLS180HJ, ZNGRLS180HS, ZNGRMS180HJ, ZNGRMS180HS, ZNGRMS180S, ZNGRS180HJ, ZNGRS180HS, ZNGRS180S Medtronic guide wires are steerable guide wires that are used for the introduction and placement of diagnostics or interventional devices in the coronary and peripheral vasculature, and may be used to reach and cross a target lesion. Medtronic guide wires are not intended for cerebral vasculature. Medtronic steerable exchange guide wires are used to facilitate the substitution of one diagnostic or interventional device for another. G13A00123 G13A00870 G13A00910 G13A00911 G13A00920 G13A00921 G13A00931 G13A00939 G13A00940 G13A01270 G13A01271 G13A01352 G13A01354 G13A01355 G13A01477 G13A01478 G13A01622 G13A01623 G13A01624 G13A01640 G13A01641 G13A01651 GV875 GV876 GW594 GW683 GW695 Class I Potential for PTFE (polytetrafluroethylene) coating to delaminate and detach from Guidewire. Medtronic Vascular
Devices THUNDER® Extra Support Guidewire; Models: THNDR190J, THNDR190S, THNDR300J, THNDR300S Medtronic guide wires are steerable guide wires that are used for the introduction and placement of diagnostics or interventional devices in the coronary and peripheral vasculature, and may be used to reach and cross a target lesion. Medtronic guide wires are not intended for cerebral vasculature. Medtronic steerable exchange guide wires are used to facilitate the substitution of one diagnostic or interventional device for another. G13A00117 G13A00735 G13A00792 G13A00794 G13A01324 GV259 GV261 GV276 GV287 GV847 GV848 GV849 GV851 GV852 GW690 GW758 Class I Potential for PTFE (polytetrafluroethylene) coating to delaminate and detach from Guidewire. Medtronic Vascular
Devices ProVia® CROSSING GUIDEWIRE; Models: 15PROV300HS, 3PROV180HS, 3PROV180SS, 3PROV300HS, 3PROV300SS Medtronic guide wires are steerable guide wires that are used for the introduction and placement of diagnostics or interventional devices in the coronary and peripheral vasculature, and may be used to reach and cross a target lesion. Medtronic guide wires are not intended for cerebral vasculature. Medtronic steerable exchange guide wires are used to facilitate the substitution of one diagnostic or interventional device for another. G13A00130 G13A01300 GT414 GU543 GV117 GV118 GV121 GV381 GV382 GV919 GW768 Class I Potential for PTFE (polytetrafluroethylene) coating to delaminate and detach from Guidewire. Medtronic guide wires are steerable guide wires that are used for the introduction and placement of diagnostics or interventional devices in the coronary and peripheral vasculature, and may be used to reach and cross a target lesion. Medtronic guide wires are not intended for cerebral vasculature. Medtronic steerable exchange guide wires are used to facilitate the substitution of one diagnostic or interventional device for another. Medtronic Vascular
Devices ATTAIN HYBRID® Guide Wire; Models: GWR419478, GWR419488, GWR419688 The Attain Hybrid guide wire is intended to aid in the placement of Medtronic transvenous left ventricular leads in the coronary vasculature. 0006752371 0006752383 0006752385 0006759937 0006759939 0006759941 0006769772 0006781453 0006781454 0006781455 0006808160 0006808161 0006808164 0006808165 0006808166 0006808167 0006831243 0006840866 0006840878 0006840879 0006866694 0006866696 0006866697 0006873688 0006873692 0006873694 Class I Potential for PTFE (polytetrafluroethylene) coating to delaminate and detach from Guidewire. Medtronic Vascular
Devices COUGAR® Steerable Guidewire; Models: LVCLS190J, LVCLS190S, LVCXT190J, LVCXT190S Medtronic guide wires are steerable guide wires that are used for the introduction and placement of diagnostics or interventional devices in the coronary and peripheral vasculature, and may be used to reach and cross a target lesion. Medtronic guide wires are not intended for cerebral vasculature. Medtronic steerable exchange guide wires are used to facilitate the substitution of one diagnostic or interventional device for another G13A00805 G13A00814 G13A00815 G13A01447 G13A01450 GW547 Class I Potential for PTFE (polytetrafluroethylene) coating to delaminate and detach from Guidewire. Medtronic Vascular
Devices THUNDER® Steerable Guidewire; Model: LVTNDR190S Medtronic guide wires are steerable guide wires that are used for the introduction and placement of diagnostics or interventional devices in the coronary and peripheral vasculature, and may be used to reach and cross a target lesion. Medtronic guide wires are not intended for cerebral vasculature. Medtronic steerable exchange guide wires are used to facilitate the substitution of one diagnostic or interventional device for another. G13A00116 G13A00936 GV260 GV846 Class I Potential for PTFE (polytetrafluroethylene) coating to delaminate and detach from Guidewire. Medtronic Vascular
Devices ZINGER® Steerable Guidewire; Models: LVZRLS180J, LVZRLS180S, LVZRMS180J, LVZRMS180S, LVZRXT180J, LVZRXT180S Medtronic guide wires are steerable guide wires that are used for the introduction and placement of diagnostics or interventional devices in the coronary and peripheral vasculature, and may be used to reach and cross a target lesion. Medtronic guide wires are not intended for cerebral vasculature. Medtronic steerable exchange guide wires are used to facilitate the substitution of one diagnostic or interventional device for another. G13A00118 G13A00715 G13A00716 G13A00843 G13A00937 G13A01601 G13A01620 G13A01621 G13A01638 G13A01639 G13A01650 GV854 GW761 Class I Potential for PTFE (polytetrafluroethylene) coating to delaminate and detach from Guidewire. Medtronic Vascular
Devices Brilliance iCT Computed Tomography X-Ray System, Product Usage: The Brilliance iCT is a Computed Tomography X-Ray System intended to produce cross-sectional images of the body by computer reconstruction of x-ray transmission data taken at different angles and planes. Model #728306, Serial #'s: 100016, 100018, 100019, 100020, 100021, 100022, 100023, 100024 and 100025. Class II If the couch, with the footrest extension attached, is positioned where the table travel is within the bore of the gantry, and the user begins to lower the couch, the footrest extension can contact the gantry cover or come in contact with the user due to the length of the accessory. Philips Medical Systems (Cleveland) Inc
Devices Fixed Offset Adapter, A-642100. The Offset Adapter is a fixed modular component which sets the tube 14.5 mm (0.57 inch) offset from the center line of the pyramid. It is made of a high-strength alloy with a pyramid receiver and is intended where there is a need to offset the tube horizontally in relation to other components. It is fully compatible with all standard 30mm prosthetic pylons. (3) Offset: 14,5mm (0.57inch). Item Number: A-642100 All Serial Numbers. Class II Ossur inititated a voluntary recall of the A-642100 Fixed Offset Adapter because it can develop fatigue cracks in normal use over an extended period of time and ultimately separate completely. Ossur North America Inc
Food CTF Brand Tapioca Pearl Pandan (Green Color), 14oz Plastic Bags, Packaged at 50 bags per case. Packaged in plastic heat-sealed pouch. Brand name is CTF with an illustration of a deer. Product labeling reads in part:"C.T.F. Brand TAPIOCA PEARL***EXPORTED: COMBINE THAI FOODS CO., LTD.***PRODUCT OF THAILAND NET WT:14OZ(400 G)***" UPC Code 8 851381 561145. No Lot Codes or Best By Dates. The product only has a UPC code for the public's identification purposes. Class II The recall has been initiated due to missing ingredients not being shown in the ingredient list of the packaging. The missing ingredients are: Artificial Color Yellow No. 5 and Brilliant Blue FD&C No. 1. N A Trading Inc
Food EDGE, Item number 21-620, dietary supplement, 60 packet per box. The Edge product includes two different packets of capsules - a "Before" packet and an "After" packet. The suggested use for the After packet is one packet (or 6 capsules) per day. The suggested use for the "Before" packet is one packet (or 4 capsules) per day. Lot BO1 and AO1, Expiration date Aug 2015 Class I EDGE dietary supplement product is recalled because the finished label does not declare shark cartilage. New Algae Company
Food Flex, Maximum Flexibility, Item number 21-601, dietary supplement, 90 capsules per bottle. The Flex product is a dietary supplement in capsule form containing vegetable glucosamine HCL, chondroitin sulfate (shark cartilage), organic microalgae (aph. flos-aquae) and chicken cartilage. The serving size is 3 capsules and the suggested use is one 3 capsule serving per day. Lot EY1, manufacturing date of 8/2013. (product expires by August 2015) Class I Flex dietary supplement product is recalled because the finished label does not declare shark cartilage. New Algae Company
Devices GE Healthcare Discovery NMCT 670, Discovery NM 630, Optima NMCT 640, & Brivo NM 615. The GE Discovery NMJCT 670 system is a medical tool intended for use by appropriately trained healthcare professionals to aid in detecting, localizing, diagnosing of diseases and organ function for the evaluation of diseases, trauma, abnormalities, and disorders such as, but not limited to, cardiovascular disease, neurological disorders and cancer. The system output can also be used by the physician for staging and restaging of tumors, planning, guiding, and monitoring therapy. The GE Discovery NM/CT 670 system, combining Nuclear Medicine (NM) and Computed Tomography (CT) systems, is intended to produce: NM System: General Nuclear Medicine imaging procedures for detection of radioisotope tracer uptake in the patient body, using a variety of scanning modes supported by various acquisition types and imaging features designed to enhance image quality. The scanning modes include planar mode (Static, Multi-gated, Dynamic and Whole body scanning) and tomographic mode (SPECT, Gated SPECT, Whole body SPECT). The acquisition types include single and multi-isotope/multi peak frame/list mode single-photon imaging. The imaging-enhancement features include assortment of collimators, gating by physiological signals, and real-time automatic body contouring. CT System: Cross sectional images of the body by computer reconstruction of X-Ray transmission data taken at different angles and planes, including Axial, Cine, Helical, Cardiac, and Gated acquisitions. These images may be obtained with or without contrast. The CT system is indicated for head, whole body, cardiac and vascular X-Ray Computed Tomography applications NM + CT System: Combined, hybrid SPECT and CT protocols, for CT-based SPECT attenuation corrected imaging as well as functional and anatomical mapping imaging (localization, registration and fusion). The GE Discovery NM/CT 670 system may include signal analysis and display equipment, patient and equipment supports, components and accessories. The system may include data and image processing to produce images in a variety of trans-axial and reformatted planes. The images can also be post processed to produce additional images, imaging planes, and analysis results. The system may be used for patients of all ages. The GE Discovery NM 630 system is a medical tool intended for use by appropriately trained healthcare professionals to aid in detecting, localizing, diagnosing of diseases and in assessment of organ function for the evaluation of diseases, trauma, abnormalities, and disorders such as, but not limited to, cardiovascular disease, neurological disorders and cancer. The system output can also be used by the physician for staging and restaging of tumors, planning, guiding, and monitoring therapy. The GE Discovery NM 630 system is a Nuclear Medicine (NM) system, which is intended to yield General Nuclear Medicine imaging procedures for detection of radioisotope tracer uptake in the patient body, using a variety of scanning modes supported by various acquisition types and imaging features designed to enhance image quality. The scanning modes include planar mode (Static, Multi-gated, Dynamic and Whole body scanning) and tomographic mode (SPECT, Gated SPECT, Whole body SPECT). The acquisition types include single and multi isotope/multi peak frame/list mode single-photon imaging. The imaging-enhancement features include assortment of collimators, gating by physiological signals, and real-time automatic body contouring. The GE Discovery NM 630 system may include signal analysis and display equipment, patient and equipment supports, components and accessories. The system may be used for patients of all ages. - The GE Optima NM/CT 640 system is intended for General Nuclear Medicine imaging procedures for detection of radioisotope tracer uptake in the patient body. It includes a general purpose Nuclear Medicine (NM) system using a variety of scann Serial # System ID 21000 262574D670 21023 309671SPECT 21030 856247NM 21032 617638DSV670 21044 404686NMCT 21045 972935D670 21054 262574D630 21062 305674D670 21065 PITT670 21069 212639NMD670 21074 423495D670 21078 615322NM5 21105 803751D670 21111 DUKECCDSV670NM 21114 614NCH670 21117 262574O640 21127 410D6701 21149 540332D670 21157 856247D670 21172 630432D670 21182 GON1409671 21188 415353D670 21189 DUKEDMP670NM  ...
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Class II GE Healthcare has recently become aware of a potential safety issue related to a SPECT scan procedure used for pulmonary imaging. Contact between the Detector (GE Healthcare Discovery NM/CT 670, and/or Optima NM/CT 640, and/or Discovery NM630, and/or Brivo NM 615 all configurations) and the Patient's elbow may occur during SPECT protocols using 450 angular steps in scenarios when a Patients arms are positioned above the head and when dedicated safety armbands are not utilized. GE Healthcare, LLC
Devices Zeiss brand IOLMaster, Version 1-5, Biomicroscope, Slit-Lamp, AC-Powered, Product is manufactured by Carl Zeiss Meditec AG (Jena), Carl Zeiss Promenade 10, Jena, Germany 07745; and distributed by Carl Zeiss Meditec, Inc., Dublin, CA This device is intended for use primarily by physicians and health care workers and may be only used under the supervision of a physician. This device will not be sold to the general public. The IOLMaster is intended for the biometric determination of ocular measurements of axial length, anterior chamber depth, corneal radius, white-to white (WTW), and for the measurement of pupil size and deviation of the visual axis from the center of the pupil. For patients who are candidates for intraocular lens (IOL) implantation, the device also performs calculations to assist physicians in determining the appropriate IOL power and type for implantation Serial Numbers: 128008 793173 793176 793179 793186 793196 797156 797185 797236 798364 798365 798366 798370 798373 798376 798413 798414 798416 798417 798426 798429 798440 798442 798444 798452 798454 798757 798759 798761 798763 798764 798765 798768 801922 801923 801924 801927 801928 801931 801934 801937 801939 801942 801943 801944 801945 801947 801949  ...
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Class II The user database delivered for download contained an erroneous value. Specifically the "aO" constant of the lens AMO Sensar AR40E is listed as "0.0" in the internal lens database of the IOLMaster. The correct value is -2.420. This could lead to the implantation of lens with a wrong diopter value. Carl Zeiss Meditec, Inc.
Devices Zeiss brand IOLMaster 500, Model 500, Biomicroscope, Slit-Lamp, AC-Powered, Product is manufactured by Carl Zeiss Meditec AG (Jena), Carl Zeiss Promenade 10, Jena, Germany 07745; and distributed by Carl Zeiss Meditec, Inc., Dublin, CA This device is intended for use primarily by physicians and health care workers and may be only used under the supervision of a physician. This device will not be sold to the general public. The IOLMaster is intended for the biometric determination of ocular measurements of axial length, anterior chamber depth, corneal radius, white-to white (WTW), and for the measurement of pupil size and deviation of the visual axis from the center of the pupil. For patients who are candidates for intraocular lens (IOL) implantation, the device also performs calculations to assist physicians in determining the appropriate IOL power and type for implantation Serial Numbers: 817123 1038929 1038930 1044483 1044485 1044487 1044488 1044489 1044490 1045639 1046055 1046056 1046057 1046343 1046344 1046345 1046353 1046355 1046364 1046373 1046374 1046376 1046377 1046378 1046380 1046381 1046488 1046489 1046500 1046509 1046514 1046516 1046523 1047089 1047090 1047091 1047092 1047093 1047101 1047107 1047111 1047266 1047267 1047268 1047269 1047270 1047271 1047272  ...
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Class II The user database delivered for download contained an erroneous value. Specifically the "aO" constant of the lens AMO Sensar AR40E is listed as "0.0" in the internal lens database of the IOLMaster. The correct value is -2.420. This could lead to the implantation of lens with a wrong diopter value. Carl Zeiss Meditec, Inc.
Devices Juggerknotless Drill Bit, REF 110003173, Sterile, Single Use Product Usage: The Juggerknotless Soft Anchors are indicated for soft tissue reattachment procedures in the shoulder, foot/ankle, hand/wrist, and hip. Catalog:110003173, Lot 127480, 185420, 233500, 233520 Class II Investigation identified that the design of the drill bit may make the suture anchor difficult to insert into the bone. The implant may skip across the hole or miss the hole during insertion. Biomet, Inc.
Devices Green Rusch - Lite Disposable Metal Laryngoscope Ridge Blade to visualize upper airway and aid in placement of tracheal tube. Product Code 004551004; Lot 1305342 Class II Labeling inconsistency Teleflex Medical
Devices Stryker 1) XIA Torque Wrench 2) XIA 3 Torque Wrench 3) XIA Elegance Short Torque Wrench Manufactured by: Stryker Spine SAS Z.I. Marticot -33610 -CESTAS -FRANCE +33 (0) 5.57.97.06.30 http://www.stryker.com Distributed in the USA by: Stryker Spine 2 Pearl Court Allendale, NJ 07401-1677 USA +1-201-760-8000 XIA 3 Spinal System- Intended for use in the noncervical spine. When used as an anterior/anterloateral and posterior, non cervical pedicle and on-pedicled fixation system, the XIA 3 Spinal system is intended to provide additional support during fusion autograft or allograft in skeletally mature patients in the treatment of the following acute and chronic instabilities or deformities; degenerate disc disease (DDD) ; spondylolisthesis; trauma spinal stenosis; curvatures; tumor; pseudoarthrosis and failed previous fusion. XIA - Intended for anterior/anterolateral and posterior, non cervical pedicle and non-pedicle fixation of the spine to provide immobilization and stabilization of spinal segments in skeletally mature patients as an adjunct to fusion for the following indications: degenerative disc disease; spondylolisthesis, trauma, spinal stenosis, curvatures, tumor, pseudoarthrosis and failed previous fusion. Medical Device Listing Number E207315 1) XIA Torque Wrench Catalog # 03807028 Lot # 127510 2) XIA 3 Torque Wrench Catalog # 48237028 Lot # 11E042, 11E044, 11E047 3) XIA Elegance Short Torque Wrench Catalog # 482397028 Lot # 11A957, 11E035, 11E036, R11E036 Class II Multiple complaints have reported that the hex tip of the torque wrench fracturing during final tightening. Stryker Spine
Devices EPIQ 7 Ultrasound System, Model 795200, 795201, 795202. Intended for diagnostic ultrasound imaging and fluid flow analysis. TRACE ITEM SERIAL NUMBERS in the UNITED STATES: US713B0171, US713B0207, US813B0017, US813B0018, US813B0019, US813B0020, US813B0022, US813B0023, US813B0024, US813B0025, US813B0122, US813B0123, US813B0125, US813B0127, US813B0128, US813B0129, US813B0131, US813B0132, US813B0134, US813B0135, US813B0233, US813B0234, US813B0235, US813B0236, US813B0237, US813B0238, US813B0239, US813B0240, US813B0423, US813B0424, US813B0425, US813B0426, US813B0427, US813B0428, US813B0429, US813B0430, US813B0431, US813B0432, US813B0433, US813B0434, US913B0033, US913B0034, US913B0035,  ...
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Class II A problem has been detected with Philips Model EPIQ 7 Ultrasound System, software version 1.0 and 1.0.1. Using the International System Date Format may result in calculation errors in Gestational Age Gestational Age (GA) and Established Due Date (EDD). Philips Medical Systems North America Inc.
Food Swanson, Premium Brand, Full Spectrum Black Cumin Seed (Nigella Sativa) Dietary Supplement capsules, 400 mg, SW1361, UPS 0 87614 11361 6. 199388, 201359 Class III Swanson Health Products is recalling two lots of Swanson Premium Full Spectrum Black Cumin Seed (Nigella sativa) Dietary Supplement Capsules. The product was found to be mislabel. Bottles of Black Cumin Seed from these two lots numbers (199399 & 201359) have been found to contain White Cumin Seed (Cuminum cyminum). Swanson Health Products, Inc
Devices Vascutek Gelsoft Vascular Graft (peripheral) Labeling reads in part, "***Gelsoft Gelatin Impregnated Knitted Vascular Prosthesis***STRAIGHT***STERILE***EO***Item No: 631508***Diameter 8mm***Usable Length 15cm***Manufactured By***VASCUTEK Ltd. a TERUMO Company Newmains Avenue Inchinnan, Renfrewshire PA4 9RR Scotland***" The Vascutek Gelsoft Vascular Prosthesis is a gelatin-sealed, woven polyester graft indicated for abdominal and peripheral vascular repair, i.e. replacement or bypass in aneurysmal and occlusive disease of arteries Catalog Number 631508 Serial Numbers: 0001765391, 0001765392, 0001765393, 0001765394, 0001765395, 0001765396, 0001765397, 0001765398, 0001765399 Class II Terumo Cardiovascular Systems (Terumo CVS) became aware of a customer complaint that a 15mm x 8mm Gelsoft graft was received which the customer believed was a 15mm x 6mm Gelsoft graft unit. The manufacturer confirmed a batch of product code 631508 was incorrectly labeled. Terumo Cardiovascular Systems Corporation
Drugs Copaxone (glatiramer acetate injection), 20 mg/1 mL, 1 mL pre-filled syringe, packaged in 30 single-use PRE-FILLED Syringes and 33 Alcohol Preps (Swabs) per carton, Rx only, Marketed by: Teva Neuroscience, Inc., Kansas City, MO 64131; Distributed by: Teva Pharmaceuticals USA, Inc., North Wales, PA 19454, NDC 68546-317-30, UPC 3 68546 31730 4. Lot X06381, Exp 10/14 Class II Presence of Particulate Matter: A foreign particle found in a pre-filled syringe was reported through a consumer complaint about a pre-filled syringe. Teva Pharmaceuticals USA
Food Best in Nature Brand Eye Care Essence, 100 Capsules. Product labeling reads in part:"Best in Nature Eye Care Essence***Dietary Supplement 100 capsules***Manufactured for: Best in Nature Walnut, CA 91789***www.1688best.com***8 92418 001069 6***". Lot Number 8956. Expiration Date 03-2016. UPC Code 8 92418 00109 6. Class II The firm initiated this recall in response to FDA sample findings that major ingredients are omitted partially or entirely. The product did not contain the amounts as labeled for Vitamin A and Vitamin C. Diamond Nutriceutical, Inc.
Devices TruSystem Surgical Table (TS7000)  Leg Section One Part Light HU Use of the Leg Section One Part Light HU is permitted only with the TRUMPF TruSystem 7000 operating table. The operating table TruSystem 7000, in conjunction with operating table components is intended for the use of patient positioning during surgery, ranging from anesthesia induction to actual surgery to recovery from anesthesia. The Leg Section One Part Light HU is attached to coupling point L on the operating table and is used to position the patients legs during pre-op and post-op surgery. Item no. 1739993, All serial numbers. Class II The coupler point (hood) of the Leg Section One Part Light may become detached from the leg section frame. Trumpf Medical Systems, Inc.
Food Trader Joe's Southwest Salads, 9oz. Packaged in plastic clamshell with ranch dressing packaged in plastic sealed solo cup. Product labeling reads in part:"TRADER JOE'S ***SOUTHWEST SALAD with Black Beans, Corn, Cotija Cheese and a tangy Ranch Dressing***NET WT. 9 OZ (255g)***DIST. & SOLD EXCLUSIVELY BY: TRADER JOE'S MONROVIA, CA 91016***". SKU 56077. Use by Date 11/2/13. Class I World Class Distribution of Fontana, California is voluntarily recalling one specific lot of Trader Joe's Southwest Salad (SKU 56077) with Use by Date 11/2/13 due to undeclared soy. World Class Distribution, Inc.
Drugs Acetaminophen suspension liquid, 160 mg/5 mL, dye-free cherry flavor, co-packaged with an oral dosing syringe in a carton and sold under the following: a) equaling infants' pain & fever acetaminophen suspension liquid, 2 FL OZ (59 mL) bottle, Distributed by SUPERVALU Inc., Eden Prairie, MN 55344, NDC 41163-590-16, UPC 0 41163 48657 7; b) Up & Up dye free infants' pain and fever acetaminophen suspension liquid, 2 FL OZ (59 mL) bottle, Distributed by Target Corporation, Minneapolis, MN 55403, NDC 11673-590-16, UPC 3 70030 62529 1; c) equate Infants' Pain & Fever acetaminophen suspension liquid, 2 FL OZ (59 mL) bottle, Distributed by: Wal-Mart Stores, Inc., Bentonville, AR 72716, NDC 49035-590-16, UPC 6 81131 00185 4; d) Meijer Infants' Pain & Fever acetaminophen oral suspension, 2 FL OZ (59 mL) bottle, Dist. By Meijer Distribution, Inc., 2929 Walker Ave. NW, Grand Rapids, MI 49544, NDC 41250-590-16, UPC 7 13733 31376 6; e) Walgreens infants' Dye-Free Pain & Fever acetaminophen oral suspension, 2 FL OZ (59 mL) bottle, Distributed By: Walgreen Co., 200 Wilmot Rd., Deerfield, IL 60015, NDC 0363-0590-16, UPC 3 11917 13222 8; f) Kroger Infants' Pain & Fever suspension liquid, 4 FL OZ (118 mL) bottle, Distributed by The Kroger Co., Cincinnati, Ohio 45202, NDC 30142-590-26, UPC 0 41260 36738 0; g) Kroger Infants' Pain & Fever acetaminophen suspension liquid, 2 FL OZ (59 mL) bottle, Distributed by The Kroger Co., Cincinnati, Ohio 45202, NDC 30142-590-16, UPC 0 41260 35829 6; h) Publix Infants' painrelief acetaminophen suspension liquid, 2 FL OZ (59 mL), Distributed By Publix Super Markets, Inc., 3300 Publix Corporate Parkway, Lakeland, FL 33811, NDC 55062-590-16, UPC 0 41415 39573 2; i) CareOne Infants' Dye-Free Pain Relief acetaminophen suspension liquid, 2 FL OZ (59 mL) bottle, Distributed By Foodhold U.S.A., LLC, Landover, MD 20785, NDC 41520-590-16, UPC 3 41520 31006 5; j) Harmon FaceValues Infants' Pain & Fever acetaminophen suspension Liquid, 2 FL OZ (59 mL), Distributed by Harmon Stores, Inc., 650 Liberty Ave., Union, NJ 07083 USA, UPC 3 70030 51018 4 2 FL OZ Lot #: 3HK0564, Exp 06/15; 3HK0672, Exp 06/15; 3JK0594, Exp 07/15; 3JK0595, Exp 08/15; 3KK0815, Exp 08/15; 4 FL OZ Lot #: 3GK0645, Exp 06/15 Class II Defective Delivery System: There is a remote potential that cartons of product could be co-packaged with an oral dosing syringe without dose markings. L. Perrigo Co.
Drugs Acetaminophen suspension liquid, 160 mg/5 mL, cherry flavor, 2 FL OZ (59 mL) bottle co-packaged with an oral dosing syringe in a carton and sold under the following: a) leader Infants' Pain & Fever acetaminophen suspension, Distributed by Cardinal Health, Dublin, Ohio 43017, NDC 37205-577-16, UPC 0 96295 12095 0; b) Walgreens infants' Pain & Fever acetaminophen oral suspension, Distributed By: Walgreen Co., 200 Wilmot Rd., Deerfield, IL 60015, NDC 0363-0161-16, UPC 3 11917 13221 1; c) Kroger Infants' Pain & Fever acetaminophen suspension liquid, Distributed by The Kroger Co., Cincinnati, Ohio 45202, NDC 30142-161-16, UPC 0 41260 35831 9; d) H-E-B Pain & Fever acetaminophen suspension Infants', Made With Pride & Care For H-E-B, San Antonio, TX 78204, NDC 37808-161-16, UPC 0 41220 88066 9; e) Babies R Us Infants' Pain & Fever acetaminophen suspension, Distributed by Toys R Us, Inc., Wayne, NJ 07470, NDC 51334-161-16, UPC 7 17851 20094 6; f) healthy accents infants' pain & fever acetaminophen suspension liquid, Distributed By: DZA Brands, LLC, Salisbury, NC 28147/Scarborough, ME 04074, NDC 55316-161-16, UPC 7 25439 95814 1; g) Health Mart Pharmacy infants' pain & fever acetaminophen suspension liquid, Distributed by McKesson, One Post Street, San Francisco, CA 94104, NDC 62011-0002-1, UPC 0 52569 13248 7 Lot #: 3HK0671, Exp 06/15; 3JK0610, Exp 07/15; 3KK0606, Exp 08/15 Class II Defective Delivery System: There is a remote potential that cartons of product could be co-packaged with an oral dosing syringe without dose markings. L. Perrigo Co.
Drugs Acetaminophen suspension liquid, 160 mg/5 mL, dye-free grape flavor, 2 FL OZ (59 mL) bottle co-packaged with an oral dosing syringe in a carton and sold under the following: a) TopCare Infants' Pain & Fever acetaminophen, Distributed by Topco Associates LLC, Elk Grove Village, IL 60007, NDC 36800-766-16, UPC 0 36800 34650 5; b) Meijer Infants' Pain & Fever acetaminophen oral suspension, Dist. By Meijer Distribution, Inc., 2929 Waler Ave. NW, Grand Rapids, MI 49544, NDC 41250-766-16, UPC 7 13733 31403 9; c) Rite Aid infants' fever reducer & pain reliever oral suspension, Distributed By: Rite Aid, 30 hunter Lane, Camp Hill, PA 17011, UPC 0 11822 35341 0; d) Walgreens infants' Dye-Free Pain & Fever acetaminophen suspension, Distributed By: Walgreen Co., 200 Wilmot Rd., Deerfield, IL 60015, NDC 0363-0766-16, UPC 3 11917 13223 5; e) Kroger Infants' Pain & Fever acetaminophen suspension liquid, Distributed by The Kroger Co., Cincinnati, Ohio 45202, NDC 30142-766-16, UPC 0 41260 35830 2 Lot #: 3GK0704, Exp 04/15; 3JK0597, Exp 08/15; 3KK0359, Exp 08/15 Class II Defective Delivery System: There is a remote potential that cartons of product could be co-packaged with an oral dosing syringe without dose markings. L. Perrigo Co.
Drugs Acetaminophen suspension liquid, 160 mg/5 mL, grape flavor, 2 FL OZ (59 mL) bottle co-packaged with an oral dosing syringe in a carton and sold under the following: a) equate Infants' Pain & Fever acetaminophen suspension liquid, Distributed by: Wal-Mart Stores, Inc., Bentonville, AZ 72716, NDC 49035-946-16, UPC 0 78742 09060 3; b) leader Infants' Pain & Fever acetaminophen suspension, Distributed by Cardinal Health, Dublin, OH 43017, NDC 37205-576-16, UPC 0 96295 12093 6; c) TopCare Infants' Pain & Fever acetaminophen, Distributed by Topco Associates LLC, Elk Grove Village, IL 60007, NDC 36800-946-16, UPC 0 36800 34645 1; d) Walgreens infants' Pain & Fever acetaminophen oral suspension, Distributed By: Walgreen Co., 200 Wilmot Rd., Deerfield, IL 60015, NDC 0363-0946-16, UPC 3 11917 13225 9; e) Kroger Infants' Pain & Fever acetaminophen suspension liquid, Distributed by The Kroger Co., Cincinnati, Ohio 45202, NDC 30142-946-16, UPC 0 41260 35832 6 Lot #: 3JK0653, Exp 07/15; 3JK0433, Exp 07/15; 3KK0817, Exp 08/15; 3JK0673, Exp 08/15; 3KK0494, Exp 08/15; 3KK0360, Exp 08/15 Class II Defective Delivery System: There is a remote potential that cartons of product could be co-packaged with an oral dosing syringe without dose markings. L. Perrigo Co.
Devices Reprocessed Diagnostic Electrophysiology (EP) Catheters and Diagnostic EP Catheter Cables, Model Numbers: D6-DR-252-RT, F6-QF-252RT, 201101, 201104, 401442, 401860, D7-A20-131-RT, 401661, 401972, 401977, 401981, 401982, C6-MR/MST4-SA, CB3434CT. Product Usage: Reprocessed diagnostic EP catheters are indicated for temporary intracardiac sensing, recording, stimulation and electrophysiological mapping of cardiac structures. Note: These devices do not support or sustain life. Diagnostic EP Catheter cables are designed as electrode cables with a multi-pin connector on the distal end and the appropriate number of tails on the proximal end. The cables interface an EP catheter with the appropriate external stimulation or recording equipment or serve as an extension cable between an EP catheter and equipment out of immediate reach. Reprocessed diagnostic electrophysiology catheter cables are indicated for use with the appropriate electrode catheter during electrophysiology studies. Lot/Serial numbers: 1529652 1535548 1538579 1538655 1562418 1562420 1568434 1568478 1596050 1258475 1596051 1535068 1535071 1535072 1559331 1363123 1406041 1531413 1533378 1533385 1535540 1596047 1596048 1471197 1539560 1539561 1541119 1596049 757895 1600879 1520424 1558826 1558827 1600880 1600881 1558103 1434511 1464987 1600882 1313231 1600883 1600884 1401578 1570964 1600670 1600671 Class II Stryker Sustainability Solutions is recalling the Reprocessed Diagnostic Electrophysiology (EP) Catheters Cables due to a potential sterility breach in the package seal. Stryker Sustainability Solutions
Food Trader Giotto's CAESAR Salad with Caesar Dressing; Perishable, keep refrigerated. Packaged in Net Wt. 8.5 oz (241 g) plastic clamshell. Manufactured for Trader Joe's Manufactured by Ghiringhelli Specialty Foods, inc. Vallejo, CA 94950. Lot 32830110 - USE BY 11/3 - UPC 0005 1613 Class I Report of mislabeled Caesar Salads with a use by date of 11/3/13 due to undeclared allergens of soy, fish and wheat on the ingredient and allergen statement. Ghiringhelli Specialty Foods Inc.
Devices Salter Labs EtCO2 Sample line 15' (4.6 M) tube, male luer connectors. Rx only; Made in Mexico; Manufacturer:Salter Labs, 100 West Sycamore Road, Arvin, CA 93203. CO2 sample line. Model number: 4515-15-25; lot numbers 071513, 071513A and 120312. Class II It has been determined that three lots of model number 4515-15-25 CO2 Sample Line 15' tube, male Luer lock connectors may contain a 30' tube instead of the 15' length. SALTER LABS
Devices CAS I/II Absorbers that are parts of the BleaseSirius Anesthesia Workstation, the BleaseFocus Anesthesia Workstation with the following part numbers: 12200900; 12200901; 12200902; 12200903; 14200100, and service kits part number 050-0659-00 and 050-0901-00. BleaseFocus Anesthesia Workstation: The Blease Frontline Plus Range, Anesthesia Machines are intended for use in the hospital environment and locations not requiring portability. It may be used for the delivery of oxygen, air and nitrous oxide in a controlled manner to various patient breathing circuits with or without the use of a mechanical ventilator, and may be used for the delivery of anesthetic vapor by use of a dismountable vaporizer. This device is intended for use only by a suitably qualified physician. BleaseSirius Anesthesia Workstation: The Spacelabs BleaseSirius Anesthesia Workstation is intended for use in the hospital environment and operating room. It may be used for the delivery of oxygen, air and nitrous oxide in a controlled manner to various patient breathing circuits with or without the use of mechanical ventilator, and may be used for the delivery of anesthetic vapor by use of a dismountable vaporizer. The device is intended for use only by a suitably qualified physician. SERIAL NUMBERS IN THE US: ABSO-001754, ABSO-004081, ABSO-100111, ABSO-100112, ABSO-100113, ABSO-100114, ABSO-100117, ABSO-100120, ABSO-100121, ABSO-100122, ABSO-100123, ABSO-100124, ABSO-100125, ABSO-100126, ABSO-100127, ABSO-100128, ABSO-100132, ABSO-100134, and ABSO-100135. SERIAL NUMBERS INTERNATIONAL: ABSO-100098, ABSO-100099, abso-100100, ABSO-100101, abso-100102, ABSO-100103, abso-100104, abso-100105, abso-100106, ABSO-100107, ABSO-100108, ABSO-100109, ABSO-100110, ABSO-100129, ABSO-100130, ABSO-100131, ABSO-100136, AND ABSO-100137. Class I Spacelabs Healthcare Ltd. of United Kingdom recalls , and Service Kits, Part Number 050-0659-00 and 050-0901-00. The Bag to-Vent switch in CAS I/II Absorbers may fail due to loose fastening hardware in an absorber. Del Mar Reynolds Medical, Ltd.
Devices Spacelabs Healthcare qube Compact Patient Monitor, Model 91390. It is a patient monitor with arrhythmia detection or alarms. The qube is intended for use under the direct supervision of a licensed healthcare practitioner, or by personnel trained in proper use of the equipment in a hospital environment. These devices determine a) when an alarm condition is violated; b) the alarm priority (i.e. high, medium or low); c) alarm limits; and d) when to initiate and terminate alarm notifications. SERIAL NUMBERS IN THE US: 1390-101940, 1390-101945, 1390-101946, 1390-101947, 1390-101948, 1390-101950, 1390-101951, 1390-101952, 1390-101953, 1390-101954, 1390-101955, 1390-101956, 1390-101957, 1390-101958, 1390-101962, 1390-101963, 1390-101971, 1390-101972, 1390-101973, 1390-101974, 1390-101979, 1390-101980, 1390-101994, 1390-102002, 1390-102003, 1390-102004, 1390-102005, 1390-102006, 1390-102007, 1390-102008, 1390-102009, 1390-102010, 1390-102011, 1390-102012, 1390-102013, 1390-102014, 1390-102015, 1390-102016, 1390-102017, 1390-102018, 1390-102019, and 1390-102020. SERIAL NUMBER INTERNATIONAL: 1390-101949,  ...
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Class II Spacelabs Healthcare qube Compact Patient Monitor, Model 91390, may fail to power ON due to incorrect programmed microcontroller component. Spacelabs Healthcare, Llc
Devices Vascu Guard, Peripheral Vascular Patch with Apex Processing. For use in peripheral vascular reconstruction. Product Code: VG0106N VG0106N VG0106N VG0106N VG0106N VG0106N VG0106N VG0106N VG0106N VG0106N VG0106N VG0106N VG0106N VG0106N VG0106N VG0106N VG0106N VG0106N VG0106N VG0106N VG0106N VG0106N VG0106N VG0106N VG0106N VG0106N VG0106N VG0106N VG0106N VG0108N VG0108N VG0108N VG0108N VG0108N VG0108N VG0108N VG0108N VG0108N VG0108N VG0108N VG0108N VG0108N VG0108N VG0108N VG0108N VG0108N VG0108N VG0108N VG0108N VG0108N VG0108N VG0108N VG0108N VG0108N VG0108N VG0108N VG0108N VG0108N VG0108N VG0108N VG0108N VG0108N VG0108N VG0108N VG0108N VG0108N VG0108N VG0108N VG0108N VG0108N VG0108N VG0108N VG0108N VG0108N VG0108N VG0108N VG0108N VG0108N VG0108N VG0108N VG0108N VG0108N VG0108N VG0108N VG0108N VG0108N VG0108N VG0108N VG0108N VG0108N VG0108N VG0108N VG0108N VG0108N VG0108N VG0108N VG0108N VG0108N VG0108N VG0108N VG0108N VG0108N VG0108N VG0108N VG0108N VG0108N VG0108N VG0108N VG0108N VG0108N VG0108N VG0108N VG0108N VG0108N VG0108N VG0108N VG0108N VG0108N VG0108N VG0108N VG0108N VG0108N VG0108N VG0108N VG0108N VG0108N VG0108N VG0108N VG0110N VG0110N VG0110N VG0110N VG0110N VG0110N VG0209N VG0209N VG0209N VG0209N VG0209N VG0209N VG0209N VG0209N VG0209N VG0209N VG0209N VG0209N VG0209N VG0209N VG0209N VG0209N VG0209N VG0209N VG0209N VG0209N VG0209N VG0209N VG0209N VG0209N VG0209N Lot Numbers: SPCE113-03C0009 SPCE113-03C0067 SPCE113-03C0082 SPCE113-04D0001 SPCE113-04D0003 SPCE113-04D0028 SPCE113-04D0107 SPCE113-05E0032 SPCE113-05E0040 SPCE113-05E0065 SPCE113-05E0092 SPCE113-06F0001 SPCE113-06F0070 SPCE113-06F0071 SPCE113-06F0132 SPCE113-07G0001 SPCE113-07G0047 SPCE113-07G0099 SPCE113-07G0100 SPCE113-07G0116 SPCE113-08H0026 SPCE113-08H0057 SPCE113-FEB0002 SPCE113-FEB0029 SPCE113-JAN0091 SPCE113-JAN0092 SPCE113-JAN0099 SPCE113-JAN0104 SPCE113-JAN0133 SPCE113-03C0001 SPCE113-03C0002 SPCE113-03C0003 SPCE113-03C0022 SPCE113-03C0023 SPCE113-03C0024 SPCE113-03C0047 SPCE113-03C0062 SPCE113-03C0063 SPCE113-03C0064 SPCE113-03C0079 SPCE113-03C0080 SPCE113-03C0081 SPCE113-04D0020 SPCE113-04D0021 SPCE113-04D0032 SPCE113-04D0053 SPCE113-04D0054 SPCE113-04D0063 SPCE113-04D0098 SPCE113-04D0099 SPCE113-04D0108 SPCE113-04D0109 SPCE113-05E0029 SPCE113-05E0030 SPCE113-05E0031 SPCE113-05E0038 SPCE113-05E0039 SPCE113-05E0051 SPCE113-05E0054 SPCE113-05E0066 SPCE113-05E0080 SPCE113-05E0081 SPCE113-05E0082 SPCE113-05E0089 SPCE113-05E0093 SPCE113-06F0023 SPCE113-06F0058 SPCE113-06F0063 SPCE113-06F0064 SPCE113-06F0072 SPCE113-06F0073 SPCE113-06F0129 SPCE113-06F0130 SPCE113-06F0131 SPCE113-07G0003 SPCE113-07G0004 SPCE113-07G0016 SPCE113-07G0041 SPCE113-07G0042 SPCE113-07G0043 SPCE113-07G0044 SPCE113-07G0078 SPCE113-07G0079 SPCE113-07G0095 SPCE113-07G0103 SPCE113-07G0104 SPCE113-07G0111 SPCE113-07G0117 SPCE113-08H0034 SPCE113-08H0053 SPCE113-08H0054 SPCE113-08H0055 SPCE113-08H0056 SPCE113-08H0066 SPCE113-08H0067 SPCE113-08H0068 SPCE113-08H0069 SPCE113-08H0070 SPCE113-08H0081 SPCE113-09I0003 SPCE113-09I0012 SPCE113-09I0021 SPCE113-FEB0006 SPCE113-FEB0007 SPCE113-FEB0031 SPCE113-FEB0032 SPCE113-FEB0062 SPCE113-FEB0063 SPCE113-FEB0064 SPCE113-FEB0065 SPCE113-FEB0066 SPCE113-FEB0074 SPCE113-FEB0076 SPCE113-FEB0077 SPCE113-FEB0078 SPCE113-FEB0104 SPCE113-JAN0035 SPCE113-JAN0086 SPCE113-JAN0087 SPCE113-JAN0089 SPCE113-JAN0090 SPCE113-JAN0093 SPCE113-JAN0101 SPCE113-JAN0102 SPCE113-JAN0103 SPCE113-JAN0119 SPCE113-JAN0120 SPCE113-JAN0134 SPCE113-04D0004 SPCE113-05E0036 SPCE113-05E0037 SPCE113-07G0046 SPCE113-FEB0058 SPCE113-JAN0040 SPCE113-03C0025 SPCE113-03C0026 SPCE113-03C0027 SPCE113-03C0065 SPCE113-03C0066 SPCE113-04D0073 SPCE113-04D0074 SPCE113-04D0111 SPCE113-05E0053 SPCE113-05E0055 SPCE113-05E0067 SPCE113-06F0002 SPCE113-06F0060 SPCE113-06F0074 SPCE113-07G0002 SPCE113-07G0081 SPCE113-07G0083 SPCE113-08H0012 SPCE113-08H0065 SPCE113-FEB0046 SPCE113-FEB0067 SPCE113-FEB0068 SPCE113-FEB0069 SPCE113-JAN0088 SPCE113-JAN0100 Class II Synovis, a subsidiary of Baxter International Inc., is recalling certain shipments of VASCUGUARD and DURA-GUARD because Synovis, a subsidiary of Baxter International Inc., is recalling certain shipments of VASCUGUARD and DURA-GUARD because the shipping configurations in which the 6 fluid ounce units containing a specific revision of the Instructions for Use (IFU) shipped in a divided cell shipping carton can place pressure on the package, which can lead to damage and leakage. Synovis Surgical Innovations, Inc.
Devices Dura Guard, Dural Repair Patch with Apex Processing. For use as a dura substitute for the closure of dura mater during neurosurgery. Product Code: DG0209SN DG0209SN DG0209SN DG0209SN DG0209SN DG0209SN DG0209SN DG0209SN DG0404SN DG0404SN DG0404SN DG0404SN DG0404SN DG0404SN DG0404SN DG0404SN DG0404SN DG0404SN DG0404SN DG0404SN DG0404SN DG0404SN DG0404SN DG0608SN DG0608SN DG0608SN DG0608SN DG0608SN DG0608SN DG0608SN DG0608SN DG0608SN DG0608SN DG0608SN DG0608SN DG0608SN DG0608SN DG0608SN DG0608SN DG0608SN DG0608SN DG0608SN Lot Numbers: SPCE113-03C0006 SPCE113-04D0002 SPCE113-04D0047 SPCE113-05E0052 SPCE113-05E0072 SPCE113-07G0077 SPCE113-08H0018 SPCE113-08H0073 SPCE113-03C0008 SPCE113-03C0072 SPCE113-04D0036 SPCE113-04D0092 SPCE113-04D0093 SPCE113-05E0047 SPCE113-05E0048 SPCE113-06F0053 SPCE113-06F0054 SPCE113-07G0008 SPCE113-07G0072 SPCE113-08H0016 SPCE113-FEB0092 SPCE113-JAN0046 SPCE113-JAN0106 SPCE113-03C0004 SPCE113-03C0069 SPCE113-03C0070 SPCE113-03C0071 SPCE113-04D0085 SPCE113-04D0086 SPCE113-05E0073 SPCE113-05E0074 SPCE113-06F0055 SPCE113-06F0057 SPCE113-06F0138 SPCE113-06F0139 SPCE113-07G0074 SPCE113-07G0075 SPCE113-08H0019 SPCE113-JAN0047 SPCE113-JAN0048 SPCE113-JAN0109 SPCE113-JAN0125 Class II Synovis, a subsidiary of Baxter International Inc., is recalling certain shipments of VASCUGUARD and DURA-GUARD because Synovis, a subsidiary of Baxter International Inc., is recalling certain shipments of VASCUGUARD and DURA-GUARD because the shipping configurations in which the 6 fluid ounce units containing a specific revision of the Instructions for Use (IFU) shipped in a divided cell shipping carton can place pressure on the package, which can lead to damage and leakage. Synovis Surgical Innovations, Inc.
Devices Candela Laser GentleLase Pro, Powered Laser Surgical Instrument for dermatological use - Model number: 9914-00-9015. and Candela Laser GentleLase Pro LE, Model number: 9914-00-9040 GL Pro Model 9914-00-9015:: SN 9914-9015-0005 through 9914-9015-1259 GL Pro LE Model 9914-00-9040: SN 9914-9040-0716 through 9914-9040-1214 Class II Unintended single pulse maybe emitted to handpiece prior to pressing of trigger or footswitch and cause injury. Candela Corporation
Food Lifeforce Medical Institute Ultra Power; Optimal Vitamin/Mi neral. Trace Element/Anti-Oxidant Detox Support Dietary Supplement. 10 tablets/Packet and 30 packets/1000cc bottle. Distributed by: Mark Rosenbloom, MD LIFEFORCE Medical Institute 60 Revere Dr., Ste. 820 Northbrook, IL 60062 (847) 905-9505 www.lifeforcemed.com 361849A, Product code CT-80924A Class II Firm was notified by supplier of the enzyme Xylanase that it was contaminated with chloramphenicol. ProThera, Inc.
Food Pro Thera Dual Detox Dietary Supplement; 60 capsules; Chlorella - 500 mg; Broccoli Sprout, dried extract - 60 mg; Enzyme Blend - supplying Beta-Glucanase, Cellulase, Protease, Hemicellulase, Phytase and Xylanase Manufactured by ProThera, Reno, NV, Lot B3222, product code DTX Class II Firm was notified by supplier of the enzyme Xylanase that it was contaminated with chloramphenicol. ProThera, Inc.
Drugs Spironolactone tablets, USP 25 mg, Rx only, 500 count bottle, Distributed By: Greenstone LLC, Peapack, NJ 07977, NDC: 59762-5011-2. Lot #: V121207, V121208, Exp 03/31/2017 Class II Marketed without an Approved NDA/ANDA: This recall is being initiated because of changes to the dissolution profile in distributed lots resulting from a manufacturing site change. There is currently no approved application supporting the alternate manufacturing site. Greenstone Llc
Drugs Spironolactone tablets, USP 50 mg, Rx only, 100 count bottle, Distributed By: Greenstone LLC, Peapack, NJ 07977, NDC: 59762-5012-1 Lot #: V121211, Exp 03/31/2017 Class II Marketed without an Approved NDA/ANDA: This recall is being initiated because of changes to the dissolution profile in distributed lots resulting from a manufacturing site change. There is currently no approved application supporting the alternate manufacturing site. Greenstone Llc
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