• Decrease font size
  • Return font size to normal
  • Increase font size
U.S. Department of Health and Human Services

Enforcement Report - Week of June 27, 2012

  • Print
  • Share
  • E-mail
-
Product Type Product Description Code Info Classification Reason for Recall Recalling Firm
Devices HEPARIN LOCK FLUSH SOLUTION, USP, 10 USP Units/mL, 1 mL Multiple Dose Vial, plastic vial, vial size 3 mL, NDC 63323-544-01, Product Code 504401, Rx only To maintain patency of an indwelling venipuncture device designed for intermittent injection or infusion therapy or blood sampling. Lot 406952 (Expiration Date 02/11) Class II CGMP Deviations: Incomplete documentation associated with test results. App Pharmaceuticals Llc
Devices HEPARIN LOCK FLUSH SOLUTION, USP, 100 USP Units/mL, 1 mL Multiple Dose Vial, plastic vial, vial size 3 mL, NDC 63323-545-01, Product Code 504501; and HEPARIN LOCK FLUSH SOLUTION, USP, 100 USP Units/mL, 5 mL Multiple Dose Vial, 500 USP Units/5 mL, plastic vial, vial size 6 mL, NDC 63323-545-05, Product Code 504505; Rx only To maintain patency of an indwelling venipuncture device designed for intermittent injection or infusion therapy or blood sampling. Product Code 504501 (1 mL): Lot 406912 (Expiration Date 01/11) and Lot 408072 (Expiration Date 09/11); Product Code 504505 (5 mL): Lot 406914 (Expiration Date 01/12) Class II CGMP Deviations: Incomplete documentation associated with test results. App Pharmaceuticals Llc
Drugs Morphine Sulfate Extended Release tablet, 30 mg, 60 tablet bottles, Rx only, Physician Total Care, Inc, Tulsa, Ok 74146-6234, NDC 54868-4033-00 PTC Drug Number: 4033. PTC Batch Number: 65IT. Batch Date: 10/13/2010. Expiration Date: 11/30/2011. NDC: 54868-4033-00 Class I Labeling: Label mix-up; Bottles labeled to contain Morphine Sulfate IR may contain Morphine Sulfate ER and vice-versa. Physicians Total Care, Inc
Drugs Morphine Sulfate Immediate Release tablet, 30 mg/120 tablet bottles, Rx only, Physician Total Care, Inc, Tulsa, OK 74146-6234, NDC 54868-4973-00 PTC Drug Number: 4973. PTC Batch Number: 65J2. Batch Date: 10/13/2010. Expiration Date: 06/30/2012. NDC: 54868-4973-00 Class I Labeling: Label mix-up; Bottles labeled to contain Morphine Sulfate IR may contain Morphine Sulfate ER and vice-versa. Physicians Total Care, Inc
Devices TX1 Tissue Removal System Console. Model: TX1 TX1 Tissue Removal System is an ultrasonic aspirator that emulsifies and removes soft tissue. The TX1 Console provides control over each mode of operation, as well as the user interface via LCD touchscreen and audible tones for confirmation of user selections. Indiciated for use in surgical procedures where fragmentation, emulsification, and aspiration of soft tissue are desirable, including General Surgery, Orthopedic Surgery, Laparoscopic Surgery and Plastic and Reconstructive Surgery. Product Codes: LFL, GEI, Serial #: 55400001, 55400002, 55400003. Part Order No: 554-0034-000 510(K) Mp.: K101561 Class II Two reasons for recall. 1. Incorrect pressure relief valve installed inside console, leading to a remote chance of a risk to health. 2. Technical Specifications, under Irrigation, the Operating Pressure value is incorrect. American Optisurgical Inc
Devices Implant, Dental, Endosseous, Acid Etched, ICE, Osseotite, Internal Connection. . Product is labeled in part: "***Certain 3.25, 13***REF IOSM313 LOT*** OSSEOTITE Certain Implant***3.25 x 13mm***CE 0086***Use by yyyy-mm***Sterile by radiation*** STERILE R***Do not re-sterile***RX only Caution: Law prohibits dispensing without prescription***do not use if package is damaged***do not reuse***consult instructions for use***Sterile unless package is opened or damaged.*** Product Usage: The BIOMET 3i Dental Implants are intended for surgical placement in the upper or lower jaw to provide a means of prosthetic attachment in single tooth restorations and in partially or fully edentulous spans with multiple single teeth utilizing delayed or immediate loading or with a terminal or intermediary abutment for fixed or removable bridgework and to retain over dentures. Lot #2010111529 Class II On November 3, 2011 Biomet 3i, Palm Beach Gardens, FL initiated a recall of their Osseotite Certain Implant, Model # IOSM313, Lot #2010111529. Dental implant lot may not have an internal thread. Biomet 3i, LLC
Food Salsa in 12 oz., 16 oz., and 5 lb. plastic containers. The product labels reads as follows: PREMIUM QUALITY Private Selection Natural***SALSA NO PRESERVATIVES KEEP REFRIGERATED NET WT 12 OZ (340g)***INGREDIENTS: Tomatoes***Jalapeno***DISTRIBUTED BY: INTER-AMERICAN PRODUCTS, CINCINNATI, OHIO 45202***1-800-697-2448***" and PREMIUM QUALITY Private Selection Natural PICO DE GALLO NO PRESERVATIVES KEEP REFRIGERATED NET WT 12 OZ (340g)***INGREDIENTS: Tomatoes***Jalapeno***DISTRIBUTED BY: INTER-AMERICAN PRODUCTS, CINCINNATI, OHIO 45202***1-800-697-2448*** and heinens" Fresh***Salsa All Natural Net. Wt. 16oz. (1lb) 454g***Ingredients: Tomatoes***Jalapeno***PACKED FOR HEINENS BY CLUB CHEF, LLC and heinens" Fresh Bruschetta All Natural Net. Wt. 16oz. (1lb) 454g ***Ingredients: Tomatoes***Jalapeno***PACKED FOR HEINENS BY CLUB CHEF, LLC Private Selection Brand: PICO DE GALLO-UPC# 11111091135, HOT SALSA-UPC# 1111091139 & MILD SALSA-UPC# 1111091137; heinen's brand: HOT SALSA-UPC# 2060100024 & MILD SALSA-UPC# 2060100026. Both brands have Use By 3/27/12. Class I South Florida Produce of Boynton Beach in Florida shipped fresh jalapeno peppers to Castellini Company in Wilder Kentucky. Castellini shipped the peppers to a store in Ohio, where the Ohio Department of Agriculture collected a sample of these peppers which subsequently were found contaminated with Salmonella. This same lot of fresh peppers was shipped to Club Chef which manufactured the Salsa which is under recall and identified in this Recall Enterprise System document. Club Chef LLC
Food "***Queso Blanco del Pais***TRIDAS***Receta Original***" 16/3/2012 Class II PR State Department sampling found positive results for Clostridium Clostridioforme Pr Supplies Co., Inc.
Food "***Queso del Pais***TRIDAS***Pasta y Queso "Guayaba"***" 16/3/2012 Class II PR State Department sampling found positive results for Clostridium Clostridioforme Pr Supplies Co., Inc.
Food "***Queso del Pais***TRIDAS***Pasta y Queso "Mango"***" 16/3/2012 Class II PR State Department sampling found positive results for Clostridium Clostridioforme Pr Supplies Co., Inc.
Devices GE Healthcare, Aestiva/5 7900 SmartVent", anesthesia machine, GE Healthcare P.O. Box 7550 Madison, WI 53707-7550. This version of the Datex-Ohmeda 7900 Ventilator is used in Datex-Ohmeda Aestiva/5 Anesthesia Systems. It is a microprocessor based, electronically controlled, pneumatically driven ventilator that provides patient ventilation during surgical procedures. The 7900 ventilator is equipped with a built-in monitoring system for inspired oxygen, airway pressure and exhaled volume. Sensors in the breathing circuit are used to control and monitor patient ventilation as well as measure inspired oxygen concentration. This allows for the compensation of compression losses, fresh gas contribution and small leakage in the breathing absorber, bellows and system. User setting and microprocessor calculations control breathing patterns. User interface keeps settings in memory. The user may change settings with a simple and secure setting sequence. A bellows contains breathing gasses to be delivered to the patient. Positive End Expiratory Pressure (PEEP) is regulated electronically. Positive pressure is maintained in the breathing system so that any leakage that occurs is outward. An RS-232 serial digital communications port connects to and communicates with external devices. Ventilatory modes for the device, include Volume Mode, Pressure Control Mode, Synchronous Intermittent Mandatory Ventilation (optional), Pressure Support with Apnea Backup Ventilation (optional). This device is to be used only by trained and qualified medical professionals Serial Number AMRP01031 AMRP00966 AMRP01030 AMRP00968 AMRP00967 AMRP01033 AMRP00970 AMRP00969 Class I GE Healthcare has recently become aware of a potential safety issue due to the interlock slide mechanism missing from the 3-vaporizer manifold of your Aestiva 7900 Anesthesia Device. This Potential for two (2) vaporizers delivering agent at the same time. This could manifest as over delivery of a single agent if both vaporizers contain the same agent or as delivery of more than one agent. This may cause prolonged or persistent hypotension requiring medical intervention. To date, no injury has been reported to GE Healthcare associated with this issue. GE Healthcare, LLC
Devices PrepStain Syringing Pipettes 240 (Catalog #490517) 100901a, 100902f, 100902f, 100903d, 100908c, 100910c, 100914f, 100916d, 100921d, 100928c, 101005a, 101007d, 101008c, 101012c, 101013a, 101015c, 101020d, 101022c, 101027a, 101028c, 101029d, 101103b, 101105h, 101110f, 101111c, 101117p, 101118n, 101119c, 101130p, 101201o, 101207o, 101208p, 101210c, 101213n, 101214b, 101214c, 101217b, 101220q, 101221g, 110104b, 110106a, 110107c, 110110d, 110112n, 110118b, 110128i, 110203i, 110210r Class III The PrepStain Syringing Pipettes may not dispense the minimum volume of 7.5 mL of the sample due to leaking. This event resulted in an increase in complaints of leaking syringing pipettes Tripath Imaging, Inc.
Devices PrepStain GYN 480 Disposable Test Kit with PreCoat Slides (Catalog #490523 100903ra, 100903rb, 100903rf, 100903rj, 100903rn, 100903rr, 100903rt, 100903rx, 100903sb, 100903sc, 100903sd, 100903se, 100903sf, 100903sl, 100910rd, 100910re, 100910rh, 100910rp, 100910rq, 100910rr, 100917rb, 100917rh, 100917rk, 100917rp, 100917rr, 100917ru, 100917sa, 100917sc, 100917se, 100924ra, 100924ri, 100924rj, 100924rl, 100924rn, 100924rp, 100924rs, 100924rt, 100924ry, 101001ra, 101001rb, 101001rc, 101001rh, 101001rm, 101001rq, 101001ru, 101001rv, 101001rw, 101001ry, 101001rz, 101008ra,  ...
More
Class III The PrepStain Syringing Pipettes may not dispense the minimum volume of 7.5 mL of the sample due to leaking. This event resulted in an increase in complaints of leaking syringing pipettes Tripath Imaging, Inc.
Devices PrepStain Installation Kit (PreCoat), Catalog/Model # 490528 100917ry, 101105sh, 110107rg Class III The PrepStain Syringing Pipettes may not dispense the minimum volume of 7.5 mL of the sample due to leaking. This event resulted in an increase in complaints of leaking syringing pipettes Tripath Imaging, Inc.
Devices Manual Method 1: 480 Test Kit (PreCoat), Catalog/Model # 490529 100903ru, 100924rr, 101022sc, 110114sh, 110225ru Class III The PrepStain Syringing Pipettes may not dispense the minimum volume of 7.5 mL of the sample due to leaking. This event resulted in an increase in complaints of leaking syringing pipettes Tripath Imaging, Inc.
Devices PrepStain GN 480 Disposable Kit Catalog/Model 490542 This is a complete kit, per the firm's explanation, that contains the PrepStain Syringing Pipettes 240, the product being recalled. The affected lots are listed under those pipettes (PrepStain Syringing Pipettes 240) This is a complete kit, per the firm's explanation, that contains the PrepStain Syringing Pipettes 240, the actual product being recalled. The affected lots are listed under those pipettes (PrepStain Syringing Pipettes 240), which are: 100901a, 100902f, 100902f, 100903d, 100908c, 100910c, 100914f, 100916d, 100921d, 100928c, 101005a, 101007d, 101008c, 101012c, 101013a, 101015c,  ...
More
Class III The PrepStain Syringing Pipettes may not dispense the minimum volume of 7.5 mL of the sample due to leaking. This event resulted in an increase in complaints of leaking syringing pipettes Tripath Imaging, Inc.
Devices Medtronic 0-arm Imaging System with Software Version 3.1.1, Catalog Numbers: BI-700-00027-120R and BI-700-00027-120. The 0-arm® Imaging System is a mobile x-ray system designed for 2D fluoroscopic and 3D imaging. Serial Numbers: 125, 156, 234R. Class II Software Version 3.1.1 does not meet navigational accuracy. Medtronic Navigation, Inc.
Devices SARNS HIGH-FLOW AORTIC ARCH CANNULA: 5.2 MM (16 FR) 00 WITH 3/8" CONNECTOR, 7.5" (19 CM) LONG. The Sarns High Flow Aortic Arch Cannula is indicated for use in perfusion of the ascending aorta during cardiopulmonary bypass surgery. Catalog number: 12315 and Lot codes: 0552019, 0557299, 0562142, 0572238, 0575869, 0579315, 0584831, 0590890, 0594622, 0598430, 0604045, 0612256, 0625339, 0640189, 0646473, 0652905, 0656574, 0666574, 0671713, and 593606C. Class II During production of one lot of the Sarns High-Flow Aortic Arch Cannula, Terumo Cardiovascular Systems (Terumo CVS) found a foreign substance on the outer surface of some cannulae connectors. Terumo CVS' preliminary investigation found that the substance can be dislodged from the cannula surface, the substance was likely deposited during the molding process, but the exact composition of the particulate is still undetermined and while Terumo CVS has no other documented instances of this substance appearing during production, it has determined that any unit manufactured within the last three years on the same mold could potentially be affected. The particulate can be dislodged from the connector surface and either adhere to the gloves of the clinician in the sterile field, or fall into the pericardial well while the surgeon is connecting the cannula to the arterial line of the cardiopulmonary bypass circuit. Terumo Cardiovascular Systems Corporation
Devices SARNS HIGH-FLOW AORTIC ARCH CANNULA: 6.5 MM (20 FR) 00 WITH 3/8" CONNECTOR, 11" (28 CM) LONG. The Sarns High Flow Aortic Arch Cannula is indicated for use in perfusion of the ascending aorta during cardiopulmonary bypass surgery. Catalog number: 12325 and Lot codes: 0551680, 0553010, 0557571, 0559882, 0562967, 0566831, 0569995, 0575870, 0579316, 0584969, 0589928, 0593454, 0595251, 0601331, 0606816, 0611597, 0617494, 0622167, 0626795, 0629156, 0632515, 0636330, 0640190, 0643858, 0649159, 0652241, 0656575, 0663510, and 621463C. Class II During production of one lot of the Sarns High-Flow Aortic Arch Cannula, Terumo Cardiovascular Systems (Terumo CVS) found a foreign substance on the outer surface of some cannulae connectors. Terumo CVS' preliminary investigation found that the substance can be dislodged from the cannula surface, the substance was likely deposited during the molding process, but the exact composition of the particulate is still undetermined and while Terumo CVS has no other documented instances of this substance appearing during production, it has determined that any unit manufactured within the last three years on the same mold could potentially be affected. The particulate can be dislodged from the connector surface and either adhere to the gloves of the clinician in the sterile field, or fall into the pericardial well while the surgeon is connecting the cannula to the arterial line of the cardiopulmonary bypass circuit. Terumo Cardiovascular Systems Corporation
Devices SARNS HIGH-FLOW AORTIC ARCH CANNULA: 6.5 MM (20 FR) 00 WITH 3/8" CONNECTOR, 11" (28 CM) LONG, WITH XCOATING SURFACE COATING. The Sarns High Flow Aortic Arch Cannula is indicated for use in perfusion of the ascending aorta during cardiopulmonary bypass surgery. Catalog number: 12325X and Lot codes: 558946, 0589263, 0603353, 0640527, and 0653443. Class II During production of one lot of the Sarns High-Flow Aortic Arch Cannula, Terumo Cardiovascular Systems (Terumo CVS) found a foreign substance on the outer surface of some cannulae connectors. Terumo CVS' preliminary investigation found that the substance can be dislodged from the cannula surface, the substance was likely deposited during the molding process, but the exact composition of the particulate is still undetermined and while Terumo CVS has no other documented instances of this substance appearing during production, it has determined that any unit manufactured within the last three years on the same mold could potentially be affected. The particulate can be dislodged from the connector surface and either adhere to the gloves of the clinician in the sterile field, or fall into the pericardial well while the surgeon is connecting the cannula to the arterial line of the cardiopulmonary bypass circuit. Terumo Cardiovascular Systems Corporation
Devices SARNS FLEXIBLE ARTERIAL CANNULA: 6.7 MM (20 FR) 00 WITH 3/8" CONNECTOR,SUTURE RING, 9.5" (24 CM) LONG. The Sarns High Flow Aortic Arch Cannula is indicated for use in perfusion of the ascending aorta during cardiopulmonary bypass surgery. Catalog number: 13010 and Lot codes: 0590855, 0593791, 0597307, 0603718, 0616892, 0624831,0629341,0634937, 0636270, 0644444, 0646144, 0653230, 0666586, and 0669487. Class II During production of one lot of the Sarns High-Flow Aortic Arch Cannula, Terumo Cardiovascular Systems (Terumo CVS) found a foreign substance on the outer surface of some cannulae connectors. Terumo CVS' preliminary investigation found that the substance can be dislodged from the cannula surface, the substance was likely deposited during the molding process, but the exact composition of the particulate is still undetermined and while Terumo CVS has no other documented instances of this substance appearing during production, it has determined that any unit manufactured within the last three years on the same mold could potentially be affected. The particulate can be dislodged from the connector surface and either adhere to the gloves of the clinician in the sterile field, or fall into the pericardial well while the surgeon is connecting the cannula to the arterial line of the cardiopulmonary bypass circuit. Terumo Cardiovascular Systems Corporation
Devices SARNS FLEXIBLE ARTERIAL CANNULA: 7.3 MM (22 FR) 00 WITH 3/8" CONNECTOR,SUTURE RING, 9.5" (24 CM) LONG. The Sarns High Flow Aortic Arch Cannula is indicated for use in perfusion of the ascending aorta during cardiopulmonary bypass surgery. Catalog number: 13020 and Lot codes: 0550552, 0555854, 0557327, 0559103, 0562503, 0566861, 0570455, 0574279, 0577885, 0581606, 0585963, 0590856, 0593457, 0597308, 0605179, 0609199, 0614248, 0618969, 0626379, 0628950, 0634171, 0636332, 0640518, 0646396, 0653231, and 0666719. Class II During production of one lot of the Sarns High-Flow Aortic Arch Cannula, Terumo Cardiovascular Systems (Terumo CVS) found a foreign substance on the outer surface of some cannulae connectors. Terumo CVS' preliminary investigation found that the substance can be dislodged from the cannula surface, the substance was likely deposited during the molding process, but the exact composition of the particulate is still undetermined and while Terumo CVS has no other documented instances of this substance appearing during production, it has determined that any unit manufactured within the last three years on the same mold could potentially be affected. The particulate can be dislodged from the connector surface and either adhere to the gloves of the clinician in the sterile field, or fall into the pericardial well while the surgeon is connecting the cannula to the arterial line of the cardiopulmonary bypass circuit. Terumo Cardiovascular Systems Corporation
Devices SARNS FLEXIBLE ARTERIAL CANNULA: 8.0 MM (24 FR) WITH 3/8" CONNECTOR,SUTURE RING, 9.5" (24 CM) LONG. The Sarns High Flow Aortic Arch Cannula is indicated for use in perfusion of the ascending aorta during cardiopulmonary bypass surgery. Catalog number: 13030 and Lot code: 0553041, 0555967, 0557330, 0559885, 0562990, 0564951, 0567668, 0570456, 0571580, 0575365, 0580822, 0583186, 0585529, 0590858, 0593455, 0596125, 0600250, 0605504, 0609198, 0614183, 0620033, 0623325, 0626858, 0634096, 0636271, 0638011, 0640980, 0650900, 0653232, and 628985C. Class II During production of one lot of the Sarns High-Flow Aortic Arch Cannula, Terumo Cardiovascular Systems (Terumo CVS) found a foreign substance on the outer surface of some cannulae connectors. Terumo CVS' preliminary investigation found that the substance can be dislodged from the cannula surface, the substance was likely deposited during the molding process, but the exact composition of the particulate is still undetermined and while Terumo CVS has no other documented instances of this substance appearing during production, it has determined that any unit manufactured within the last three years on the same mold could potentially be affected. The particulate can be dislodged from the connector surface and either adhere to the gloves of the clinician in the sterile field, or fall into the pericardial well while the surgeon is connecting the cannula to the arterial line of the cardiopulmonary bypass circuit. Terumo Cardiovascular Systems Corporation
Devices SARNS FLEXIBLE ARTERIAL CANNULA: 8.0 MM (24 FR) 00 WITH 3/8" CONNECTOR, CM MARKING, 10" (25 CM) LONG. The Sarns High Flow Aortic Arch Cannula is indicated for use in perfusion of the ascending aorta during cardiopulmonary bypass surgery. Catalog number: 144776 and Lot code: 0552165, 0560615, 0574341, 0586004, 0606472, 0614321, 0617360, 0622689, 0637775, 0640519, and 0653855. Class II During production of one lot of the Sarns High-Flow Aortic Arch Cannula, Terumo Cardiovascular Systems (Terumo CVS) found a foreign substance on the outer surface of some cannulae connectors. Terumo CVS' preliminary investigation found that the substance can be dislodged from the cannula surface, the substance was likely deposited during the molding process, but the exact composition of the particulate is still undetermined and while Terumo CVS has no other documented instances of this substance appearing during production, it has determined that any unit manufactured within the last three years on the same mold could potentially be affected. The particulate can be dislodged from the connector surface and either adhere to the gloves of the clinician in the sterile field, or fall into the pericardial well while the surgeon is connecting the cannula to the arterial line of the cardiopulmonary bypass circuit. Terumo Cardiovascular Systems Corporation
Devices 24FR FLEX ART CANN NON STERILE. The Sarns High Flow Aortic Arch Cannula is indicated for use in perfusion of the ascending aorta during cardiopulmonary bypass surgery. Catalog number: 88813030 and Lot code: 0550551, 0568495, 0576844, 0586459, 0601958, 0626874, and 0635682. Class II During production of one lot of the Sarns High-Flow Aortic Arch Cannula, Terumo Cardiovascular Systems (Terumo CVS) found a foreign substance on the outer surface of some cannulae connectors. Terumo CVS' preliminary investigation found that the substance can be dislodged from the cannula surface, the substance was likely deposited during the molding process, but the exact composition of the particulate is still undetermined and while Terumo CVS has no other documented instances of this substance appearing during production, it has determined that any unit manufactured within the last three years on the same mold could potentially be affected. The particulate can be dislodged from the connector surface and either adhere to the gloves of the clinician in the sterile field, or fall into the pericardial well while the surgeon is connecting the cannula to the arterial line of the cardiopulmonary bypass circuit. Terumo Cardiovascular Systems Corporation
Devices SPECIALTYCARE - HUDGENS. The Sarns High Flow Aortic Arch Cannula is indicated for use in perfusion of the ascending aorta during cardiopulmonary bypass surgery. Catalog number: 64625 and Lot code: NA17, NC07A, NG06, NG06A, and NL19. Class II During production of one lot of the Sarns High-Flow Aortic Arch Cannula, Terumo Cardiovascular Systems (Terumo CVS) found a foreign substance on the outer surface of some cannulae connectors. Terumo CVS' preliminary investigation found that the substance can be dislodged from the cannula surface, the substance was likely deposited during the molding process, but the exact composition of the particulate is still undetermined and while Terumo CVS has no other documented instances of this substance appearing during production, it has determined that any unit manufactured within the last three years on the same mold could potentially be affected. The particulate can be dislodged from the connector surface and either adhere to the gloves of the clinician in the sterile field, or fall into the pericardial well while the surgeon is connecting the cannula to the arterial line of the cardiopulmonary bypass circuit. Terumo Cardiovascular Systems Corporation
Devices CUSTOM CPB CATHETER KIT-DR. The Sarns High Flow Aortic Arch Cannula is indicated for use in perfusion of the ascending aorta during cardiopulmonary bypass surgery. Catalog number: 80001-01 and Lot code: MG21, MM04, NA24, ND21, NK01, NM31, and PA30. Class II During production of one lot of the Sarns High-Flow Aortic Arch Cannula, Terumo Cardiovascular Systems (Terumo CVS) found a foreign substance on the outer surface of some cannulae connectors. Terumo CVS' preliminary investigation found that the substance can be dislodged from the cannula surface, the substance was likely deposited during the molding process, but the exact composition of the particulate is still undetermined and while Terumo CVS has no other documented instances of this substance appearing during production, it has determined that any unit manufactured within the last three years on the same mold could potentially be affected. The particulate can be dislodged from the connector surface and either adhere to the gloves of the clinician in the sterile field, or fall into the pericardial well while the surgeon is connecting the cannula to the arterial line of the cardiopulmonary bypass circuit. Terumo Cardiovascular Systems Corporation
Devices CPB CATHETER KIT- DR.VAN TRIGHT. The Sarns High Flow Aortic Arch Cannula is indicated for use in perfusion of the ascending aorta during cardiopulmonary bypass surgery. Catalog number: 80004-02 and Lot code: MG07, MK02, MM11, MN15, MP13, ND28, NE25, NN21, and PA23. Class II During production of one lot of the Sarns High-Flow Aortic Arch Cannula, Terumo Cardiovascular Systems (Terumo CVS) found a foreign substance on the outer surface of some cannulae connectors. Terumo CVS' preliminary investigation found that the substance can be dislodged from the cannula surface, the substance was likely deposited during the molding process, but the exact composition of the particulate is still undetermined and while Terumo CVS has no other documented instances of this substance appearing during production, it has determined that any unit manufactured within the last three years on the same mold could potentially be affected. The particulate can be dislodged from the connector surface and either adhere to the gloves of the clinician in the sterile field, or fall into the pericardial well while the surgeon is connecting the cannula to the arterial line of the cardiopulmonary bypass circuit. Terumo Cardiovascular Systems Corporation
Drugs Jolessa (levonorgestrel/ethinyl estradiol tablets, USP) 0.15 mg/0.03 mg, each Dispenser contains 91 tablets, 91 Day Regimen, Rx Only, Shaping Women's Health, Manufactured by: Barr Laboratories, Inc., Pomona, NY 10970, Manufactured for: Teva Pharmaceuticals USA, Sellersville, PA 18960, NDC 0555-9123-66. Lot #'s 33801826A, Exp 1/2013; 33802144A; 33802323A, Exp 3/2013; 33802519A, Exp 6/2013 Class III Contraceptive Tablets Out of Sequence: This recall has been initiated due to the potential that some regimen packages may not contain placebo tablets. Teva Pharmaceuticals USA, Inc.
Devices VerifyNow P2Y12 Assay, Part Number: 85064, All reagent lots. Product Usage: The VerifyNow P2Y12 assay device is a whole blood assay used in the laboratory or point of care setting to measure the level of platelet P2Y12 receptor blockade. The VerifyNow Systems intended for use with human whole blood and verify now test devices. The system should be operated by healthcare professionals trained on use of the system and in accordance with institution and policies and procedures. Accumetrics respresentatives will assist your institution in the installation of the system and operations of the operator. Lot # WK0002A WK0003A WK0003B WK0004A WK0005A WK0006A WK0006B WK0006AR WK0006BR WK0007A WK0008A WK0009A WK0010A WK0010B WK0010C WK0011A WK0012A WK0013A WL0001A WL0001B WK0014A WK0015A WL0003A WL0004A WK0016A WL0005A WL0006A WL0007A WK0017A WK0018A WL0007B WL0008A WK0018B WK0018-5A WL0008-5A WL0009A WL0009-5A WK0019A WL0009B WL0010A WL0010-5A WL0010B WL0011-5A WL0011A WL0013A WL0012A WL0012-5A WL0015-5A WL0015A WL0016-5A WL0016A WL0017A WL0018A WL0018-5A WL0019A WL0020A WL0020-5A WL0018B WK0020A WL0021A WL0022A WL0023A WL0023-5A WL0024A WL0024B WL0025A WL0026A WL0026A WL026-5A WL0027 WL0028 WL0029 WL0029A WL0029B WL0030 WL0031 WL0030A WL0033 WL0034 WL0035 WL0036 WL0038 WL0033A WL0039 WL0040 WL0040A WL0041 WL0042 WL0043 WL0044 WL0045 WL0046 WL0045A WL0049 WL0049A WL0051 WL0051A WL0052 WL0053 WL0055 WL0056 WL0057 WL0057A WL0059 WL0060 WL0061 WL0061A WL0062 WL0062A WL0061A WL0063 WL0062B WL0064 WL0065 WL0067 WL0069 WL0070 WL0071 WL0066A WL0068A WL0072 WL0073 WL0074 WL0075 WL0076 WL0078 WL0079 WL0080 WL0081 WL0076A WL0082 WL0083 WL0084 WL0088 WL0089A WL0091 WL0090 WL0093 WL0097 WL0098 WL0099 WL0101 WL0102 WL0105 WL0106 WL0108 WL0111 WL0111A WL0113 WL0117 WL0118 Class II The recall was initiated by Accumetrics because of a field correction to the VerifyNow System; specifically the results reported when running the VerifyNow P2Y12 Test. Currently the VerifyNow P2Y12 Test reports three values: PRU, BASE and % Inhibition. The change implemented is the elimination of the BASE and % Inhibition results. There will be no change to the reporting of the PRU result which will be the only value reported. Accumetrics Inc
Devices VerifyNow System, part #85005-6H Product Usage: The VerifyNow P2Y12 assay device is a whole blood assay used in the laboratory or point of care setting to measure the level of platelet P2Y12 receptor blockade. The VerifyNow Systems intended for use with human whole blood and verify now test devices. The system should be operated by healthcare professionals trained on use of the system and in accordance with institution and policies and procedures. Accumetrics respresentatives will assist your institution in the installation of the system and operations of the operator. Not available Class II The recall was initiated by Accumetrics because of a field correction to the VerifyNow System; specifically the results reported when running the VerifyNow P2Y12 Test. Currently the VerifyNow P2Y12 Test reports three values: PRU, BASE and % Inhibition. The change implemented is the elimination of the BASE and % Inhibition results. There will be no change to the reporting of the PRU result which will be the only value reported. Accumetrics Inc
Devices NIDEK Medical M5C5/ MARK5 NUVO/STD, 230 V~50/60 Hz - 420 W. Oxygen Concentrator. Serial numbers 042-10000 through 102-07044 Class I Capacitor failure may result in a fire hazard and loss of supplemental oxygen. Nidek Medical Products Inc
Devices NIDEK Medical M5C5/ MARK5 NUVO/OCSI, 230 V~50/60 Hz -420 W. Oxygen Concentrator. Serial numbers 042-10000 through 102-07044 Class I Capacitor failure may result in a fire hazard and loss of supplemental oxygen. Nidek Medical Products Inc
Devices NIDEK Medical MARK5 NUVO 8 STD, 115 V~60Hz - 500W. Oxygen Concentrator. Serial numbers 042-10000 through 102-07044 Class I Capacitor failure may result in a fire hazard and loss of supplemental oxygen. Nidek Medical Products Inc
Devices NIDEK Medical MARK5 NUVO 8 /OCSI, 230 V~50/60Hz - 420 W. Oxygen Concentrator. Serial numbers 042-10000 through 102-07044 Class I Capacitor failure may result in a fire hazard and loss of supplemental oxygen. Nidek Medical Products Inc
Devices NIDEK Medical NUVO LITE MODEL 525 OCSI, 115V -60Hz - 330W. Oxygen Concentrator. Serial numbers 042-10000 through 102-07044 Class I Capacitor failure may result in a fire hazard and loss of supplemental oxygen. Nidek Medical Products Inc
Devices NIDEK Medical NUVO LITE MODEL 520 STD, 115V - 60Hz - 330W. Oxygen Concentrator. Serial numbers 042-10000 through 102-07044 Class I Capacitor failure may result in a fire hazard and loss of supplemental oxygen. Nidek Medical Products Inc
Devices NIDEK Medical NUVO LITE MODEL 925 OCSI, 230V - 50Hz - 300W. Oxygen Concentrator. Serial numbers 042-10000 through 102-07044 Class I Capacitor failure may result in a fire hazard and loss of supplemental oxygen. Nidek Medical Products Inc
Devices NIDEK Medical NUVO LITE MODEL 925 OCSI, 3LPM 230V - 60Hz - 280W. Oxygen Concentrator. Serial numbers 042-10000 through 102-07044 Class I Capacitor failure may result in a fire hazard and loss of supplemental oxygen. Nidek Medical Products Inc
Devices NIDEK Medical MARK5 NUVO / M5C5, 115 V ~60Hz - 410 W. Oxygen Concentrator. Serial numbers 042-10000 through 102-07044 Class I Capacitor failure may result in a fire hazard and loss of supplemental oxygen. Nidek Medical Products Inc
Food Casa de Mesquite brand Mesquite Bean Flour, packaged in 10 kg bag in carton, and 13 kg bag in carton for food manufacturing, and 10, 24 and 44 oz retail bags; Product is processed and packaged by Casa de Mesquite, LLC, Hollister, CA Lot #: 123001 Class II Recent tests show that one lot of this product has the potential to be contaminated with bacillus cereus, a spoilage organism which can cause diarrhea, nausea and other symptoms. Casa De Mesquite Llc
Devices US-001 Rev A brochure is a two sided tri-fold printed marketing brochure describing the approved labeling indications for use, precautions and general operational information of the Exer-Rest device, Models AT3800 and AT4700. Ever-Rest US Brochure US-001 Rev A. Brochure: "***AT acceleration THERAPEUTICS***At Non-Invasive Medical Solutions (NIMS) we pride ourselves on being at the forefront of developing drug free wellness solutions coupled with accredited peer-reviewed clinical research...***Whole Body Periodic Acceleration (WBPA) therapy has been demonstrated to naturally activate the release of beneficial mediators like Nitric Oxide (NO) throughout the vasculature.***Nitric Oxide [NO] supports the functioning of endothelial cells that line the arterial walls. NO signals vascular smooth muscle to relax, thereby increasing blood flow through arteries and veins. With age arterial production and availability of Nitric oxide declines.***NiMS 4400 Biscayne Blvd., Miami, FL 33137 P 305.575.4200 F 305357534201***info@nims-inc.com www.nims-inc.com***NIMS, Acceleration Therapeutics and Exer-Rest are registered trademarks of Non-Invasive Monitoring Systems, Inc.***US-001 Rev A***" Printed marketing brochure Brochure US-001 Rev A Class II Non-Invasive Monitoring Systems Inc (NIMS) is voluntarily recalling promotional materials which contain unsubstantiated direct and indirect claims. Non-Invasive Monitoring Systems, Inc.
Devices USA-002 Rev A brochure is a two sided tri-fold printed marketing brochure describing the approved labeling indications for use, precautions and general operational information of the Exer-Rest device, Models AT3800 and AT4700. Brochure: "EXER-REST***A patented, FDA registered, Acceleration Therapeutics device delivering Whole Body Periodic Acceleration to the user for symptomatic relief of a wide range of complaints***Whole Body Periodic Acceleration (WBPA)***WBPA is accomplished utilizing the Ever-Rest device to move the body repetitively head to foot at approximately 140 times a minute. This repetitive motion adds pulses to your natural vascular pulse with each acceleration and deceleration of the body. These additional pulses act on the inner lining of blood vessels (endothelium) throughout the body, a process called pulsatile shear stress, to promote the release of beneficial substances (mediators). These mediators, such as nitric oxide, provide a wide range of health benefits that originate from the user's own body.***Nitric Oxide (NO) is released from endothelial cells that line the arterial walls. NO signals vascular smooth muscle to relax, thereby increasing blood flow throughout the circulation.***NiMS 4400 Biscayne Blvd., Miami, FL 33137 P 305.575.4200 F 305357534201***info@nims-inc.com www.nims-inc.com***NIMS, Acceleration Therapeutics and Exer-Rest are registered trademarks of Non-Invasive Monitoring Systems, Inc.***USA-002 Rev A***" Printed marketing brochure Brochure USA-002 Rev A Class II Non-Invasive Monitoring Systems Inc (NIMS) is voluntarily recalling promotional materials which contain unsubstantiated direct and indirect claims. Non-Invasive Monitoring Systems, Inc.
Devices Philips Easy Diagnost Product Usage: Stationary Fluoroscopic system All systems with Eleva software version 4.x and stitching option. Class II If a lead ruler is not positioned in the same plane as the anatomical image detail to be measured, measured object distances (using the ruler) can be wrong by a corresponding factor. If, additionally, the measurement tool is not used to check the ruler, or is used in the right way (ie: calibration), such calibration error is not detected. As a result of this, a surgical intervention may be executed unnecessarily. Usability is identified to be the main contributing factor. Philips Healthcare Inc.
Drugs Zemplar (paricalcitol) Injection, 5 mcg/mL in 2 mL multi-dose vials, 25 vial carton, Rx only, Manufactured by Hospira, Inc. For Abbott Laboratories, North Chicago, IL 60064, USA, NDC 0074-1658-05 Lot #: 11-122-DK, Exp 10/13 Class II CGMP Deviations: There is potential that Abbott's third party manufacturer, Hospira, may have applied a foreign (incorrect) stopper to vials in a specific lot of Zemplar Injection. Abbott Laboratories
Food Santos Brand, Bulgar Wheat, flour packed in clear plastic bags, 2 lbs. There is no UPC code/lot code/expiration date on products. Class I The recall was initiated after it was discovered during a routine inspection that the products i.e. various kinds of flours, legumes and spices were cross packaged on shared equipment with peanuts and wheat flour. The products i.e. various kinds of flours, legumes and spices were distributed in packaging that did not reveal the presence of peanuts or wheat, but may contain traces of it. Santos Inc.
Food Santos Brand, All Purpose flour packed in clear plastic bags, 2 lbs, 5lbs There is no UPC code/lot code/expiration date on products. Class I The recall was initiated after it was discovered during a routine inspection that the products i.e. various kinds of flours, legumes and spices were cross packaged on shared equipment with peanuts and wheat flour. The products i.e. various kinds of flours, legumes and spices were distributed in packaging that did not reveal the presence of peanuts or wheat, but may contain traces of it. Santos Inc.
Food Santos Brand, Cinnamon Sticks packed in clear plastic bags, 7oz, 14oz There is no UPC code/lot code/expiration date on products. Class I The recall was initiated after it was discovered during a routine inspection that the products i.e. various kinds of flours, legumes and spices were cross packaged on shared equipment with peanuts and wheat flour. The products i.e. various kinds of flours, legumes and spices were distributed in packaging that did not reveal the presence of peanuts or wheat, but may contain traces of it. Santos Inc.
Food Santos Brand, Cumin Seeds packed in clear plastic bags, 7 ounces, 14 ounces, 2 pounds There is no UPC code/lot code/expiration date on products. Class I The recall was initiated after it was discovered during a routine inspection that the products i.e. various kinds of flours, legumes and spices were cross packaged on shared equipment with peanuts and wheat flour. The products i.e. various kinds of flours, legumes and spices were distributed in packaging that did not reveal the presence of peanuts or wheat, but may contain traces of it. Santos Inc.
Food Santos Brand, Fennel Seeds packed in clear plastic bags, 3.5 ounces, 7 ounces, 14 ounces, 2 pounds There is no UPC code/lot code/expiration date on products. Class I The recall was initiated after it was discovered during a routine inspection that the products i.e. various kinds of flours, legumes and spices were cross packaged on shared equipment with peanuts and wheat flour. The products i.e. various kinds of flours, legumes and spices were distributed in packaging that did not reveal the presence of peanuts or wheat, but may contain traces of it. Santos Inc.
Food Santos Brand, Deggi Mirch (Red Capsicum & Kashmiri Red Chile Powder) packed in clear plastic bags, 7 ounces, 14 ounces, 2 pounds There is no UPC code/lot code/expiration date on products. Class I The recall was initiated after it was discovered during a routine inspection that the products i.e. various kinds of flours, legumes and spices were cross packaged on shared equipment with peanuts and wheat flour. The products i.e. various kinds of flours, legumes and spices were distributed in packaging that did not reveal the presence of peanuts or wheat, but may contain traces of it. Santos Inc.
Food Santos Brand, Garam Masala (Indian Spice Mix) packed in clear plastic bags, 7 ounces, 16 ounces There is no UPC code/lot code/expiration date on products. Class I The recall was initiated after it was discovered during a routine inspection that the products i.e. various kinds of flours, legumes and spices were cross packaged on shared equipment with peanuts and wheat flour. The products i.e. various kinds of flours, legumes and spices were distributed in packaging that did not reveal the presence of peanuts or wheat, but may contain traces of it. Santos Inc.
Food Santos Brand, Ginger Powder packed in clear plastic bags, 7 ounces, 14 ounces, 2 pounds There is no UPC code/lot code/expiration date on products. Class I The recall was initiated after it was discovered during a routine inspection that the products i.e. various kinds of flours, legumes and spices were cross packaged on shared equipment with peanuts and wheat flour. The products i.e. various kinds of flours, legumes and spices were distributed in packaging that did not reveal the presence of peanuts or wheat, but may contain traces of it. Santos Inc.
Food Santos Brand, Cardamom packed in clear plastic bags, 3.5 ounces, 7 ounces There is no UPC code/lot code/expiration date on products. Class I The recall was initiated after it was discovered during a routine inspection that the products i.e. various kinds of flours, legumes and spices were cross packaged on shared equipment with peanuts and wheat flour. The products i.e. various kinds of flours, legumes and spices were distributed in packaging that did not reveal the presence of peanuts or wheat, but may contain traces of it. Santos Inc.
Food Santos Brand, Whole Mace packed in clear plastic bags, 3.5 ounces, 7 ounces There is no UPC code/lot code/expiration date on products. Class I The recall was initiated after it was discovered during a routine inspection that the products i.e. various kinds of flours, legumes and spices were cross packaged on shared equipment with peanuts and wheat flour. The products i.e. various kinds of flours, legumes and spices were distributed in packaging that did not reveal the presence of peanuts or wheat, but may contain traces of it. Santos Inc.
Food Santos Brand, Mustard Seeds packed in clear plastic bags, 3.5 ounces, 16 ounces There is no UPC code/lot code/expiration date on products. Class I The recall was initiated after it was discovered during a routine inspection that the products i.e. various kinds of flours, legumes and spices were cross packaged on shared equipment with peanuts and wheat flour. The products i.e. various kinds of flours, legumes and spices were distributed in packaging that did not reveal the presence of peanuts or wheat, but may contain traces of it. Santos Inc.
Food Santos Brand, Urid Split (Lentils) packed in clear plastic bags, 2 pounds, 4 pounds There is no UPC code/lot code/expiration date on products. Class I The recall was initiated after it was discovered during a routine inspection that the products i.e. various kinds of flours, legumes and spices were cross packaged on shared equipment with peanuts and wheat flour. The products i.e. various kinds of flours, legumes and spices were distributed in packaging that did not reveal the presence of peanuts or wheat, but may contain traces of it. Santos Inc.
Food Santos Brand, Suji (Farina) packed in clear plastic bags, 2 pounds There is no UPC code/lot code/expiration date on products. Class I The recall was initiated after it was discovered during a routine inspection that the products i.e. various kinds of flours, legumes and spices were cross packaged on shared equipment with peanuts and wheat flour. The products i.e. various kinds of flours, legumes and spices were distributed in packaging that did not reveal the presence of peanuts or wheat, but may contain traces of it. Santos Inc.
Food Santos Brand, garbanzo beans packed in clear plastic bags, 2 pounds, 4 pounds There is no UPC code/lot code/expiration date on products. Class I The recall was initiated after it was discovered during a routine inspection that the products i.e. various kinds of flours, legumes and spices were cross packaged on shared equipment with peanuts and wheat flour. The products i.e. various kinds of flours, legumes and spices were distributed in packaging that did not reveal the presence of peanuts or wheat, but may contain traces of it. Santos Inc.
Food Diced Red Onions, 7oz clear plastic clamshell labeled Gills Onions with the May 17, 2012 use by date, United States UPC 6 43550 00041 2. Fresh Diced Red Onions, Oignons rouges frais, en des, 198 grams, Canadian UPC 6 43550 00045 0. lot code 51RDA1A2119 Class I The recall was initiated because Gills Onions, LLC was informed by FDA of lab results from the Canadian Food Inspection Agency that diced red onions with lot # 51RDA1A2119 may be contaminated with Listeria monocytogenes. Gills Onions, LLC
Food 3/8" Diced Red Onions, 5 LB. Bag lot code 51RDA1A2119 Class I The recall was initiated because Gills Onions, LLC was informed by FDA of lab results from the Canadian Food Inspection Agency that diced red onions with lot # 51RDA1A2119 may be contaminated with Listeria monocytogenes. Gills Onions, LLC
Food 1/4" Diced Red Onions, 5 LB. Bag lot code 51RDA1A2119 Class I The recall was initiated because Gills Onions, LLC was informed by FDA of lab results from the Canadian Food Inspection Agency that diced red onions with lot # 51RDA1A2119 may be contaminated with Listeria monocytogenes. Gills Onions, LLC
Devices The product is Pathfinder SL, version 1.6.0.3057 software used with the Spacelabs Healthcare Pathfinder SL Holter Analyzer, version 1.6.0. Product Usage: The Holter Analyzer analyzes information collected from ambulatory electrocardiogram recorders worn by patients and used to assist physicians in diagnosis and patient monitoring. In addition, incorrect QTc values are reported after moving the cursor. QTc values are timing events between labeled points of interest in the ECG signal that the physician can mark with the cursor. The software is used to edit a family of events and upon conclusion the software crashes with an error message. Version 1.6.0. Class II The firm received reports of the Pathfinder LS software crashing after editing a batch of Holter Analyzer records. The software will stop with an error message requiring a restart. In addition, QTc values will not update after moving the marker. Spacelabs Healthcare, Llc
Drugs LifeGas OXYGEN COMPRESSED UN1072 USP, Distributed by: Linde LOT#: 117H201 LOT#: 117H202 Class II CGMP Deviations: The pressure gages, vacuum gages, and thermometer had surpassed the calibration expiry period, which may have resulted in overfill/underfill of oxygen cylinders. Linde Gas LLC
Devices Philips Digital Diagnost Software, software release 2.0.2 and 2.0.2SP1 including mirror icon Stationary Fluoroscopic system Software release 2.0.2 and 2.0.2SP1 including mirror icon Class II With Digital Diagnost (DIDI) R 2.0.2 a mirrored "R in a circle" is burnt into the image (if mirrored) in the lower right corner of the image. When such an image is mirrored back inside the PACS system, an unmirrored "R in a circle" appears in the lower left corner. This can be mistaken for a "right patient side" marker, although this can appear on the left patient side Philips Healthcare Inc.
Devices Boston Scientific Profile Single-Use Pediatric Snare 11mm UPN Outer Box M00562531 Inner Pouch: M00562530 , The single-use Profile Polypectomy Snare consists of a flexible wire cable loop which can be extended and retracted from the snare's flexible outer sheath using a three-ring handle. When passed through an endoscope and activated, the snare delivers a monopolar electrical current to cut and cauterize tissue with the loop Lot Numbers: 14951476, 14951479, 14987882,15068203 Class II Difficulty in extending snare loop from the catheter Boston Scientific Corporation
Devices Boston Scientific Profile Single-Use Pediatric Snare 13mm UPN Outer Box: M00562551 Inner Pouch: M00562550 The single-use Profile Polypectomy Snare consists of a flexible wire cable loop which can be extended and retracted from the snare's flexible outer sheath using a three-ring handle. When passed through an endoscope and activated, the snare delivers a monopolar electrical current to cut and cauterize tissue with the loop Lot Numbers: 14951482, 14951484, 15068143 Class II Difficulty in extending snare loop from the catheter Boston Scientific Corporation
Devices Boston Scientific Profile Single-Use Pediatric Snare 27mm UPN Outer Box: M00562571 Inner Pouch: M00562570 The single-use Profile Polypectomy Snare consists of a flexible wire cable loop which can be extended and retracted from the snare's flexible outer sheath using a three-ring handle. When passed through an endoscope and activated, the snare delivers a monopolar electrical current to cut and cauterize tissue with the loop Lot Number: 14974048 Class II Difficulty in extending snare loop from the catheter Boston Scientific Corporation
Food Shiitake-Ya brand Dried Shiitake mushroom slices, 6 oz plastic jars, UPC 7 1452 22183 9. Product labeling reads in part: " Shiitake-Ya gourmet Shiitake SLICES***Antioxidants Amino Acids Omega 3+6***Immune-Boosting*** NET WEIGHT. 6 oz (170 g)***Natural Enzymes Fiber (80% Chitin) Iron Kojic Acid Item # 26211, Sell by 041613 Class III Shiitake-Ya Gourmet Shiitake slices are being recalled because FDA test analysis showed presence of pesticide and polycyclic aromatic hydrocarbon residues: 0.208 ppm carbendazim, 0.072 ppm Fluoranthene and 0.092 ppm Pyrene. There are no tolerances for any of these pesticide residues. LA Link Corporation
Devices Covidien ROTICULATOR 55-3.5 Single Use Stapler REF# 017612 The RETICULA TOR TM Single Use Staplers have applications in abdominal, gynecologic and pediatric surgery for resection, transection, and creation of anastomosis LOT #'s BEGINNING WITH THE FOLLOWING LETTER/NUMBER COMBINATIONS P7E P8B P8L P9H POE PIB PIL P7F P8C P8M P9J POF PIC PlM P7G P8D P9A P9K POG PlD P2A P7H P8E P9B P9L POH PIE P2B0153X P7J P8F P9C P9M POJ PlF P7K P8G P9D POA POK PlG P7L P8H P9E POB POL  ...
More
Class II Potential for the sterility barrier to be compromised. Covidien LP
Devices Covidien ROTICULATOR 55-4.8 Single Use Stapler REF# 017614 The RETICULA TOR TM Single Use Staplers have applications in abdominal, gynecologic and pediatric surgery for resection, transection, and creation of anastomosis LOT #'s BEGINNING WITH THE FOLLOWING LETTER/NUMBER COMBINATIONS P7E P8B P8L P9H POE PIB PIL P7F P8C P8M P9J POF PIC PlM P7G P8D P9A P9K POG PlD P2A P7H P8E P9B P9L POH PIE P2B0153X P7J P8F P9C P9M POJ PlF P7K P8G P9D POA POK PlG P7L P8H P9E POB POL  ...
More
Class II Potential for the sterility barrier to be compromised. Covidien LP
Devices Covidien ROTICULATOR 30-3.5 Single Use Stapler REF# 017615 The RETICULA TOR TM Single Use Staplers have applications in abdominal, gynecologic and pediatric surgery for resection, transection, and creation of anastomosis LOT #'s BEGINNING WITH THE FOLLOWING LETTER/NUMBER COMBINATIONS P7E P8B P8L P9H POE PIB PIL P7F P8C P8M P9J POF PIC PlM P7G P8D P9A P9K POG PlD P2A P7H P8E P9B P9L POH PIE P2B0153X P7J P8F P9C P9M POJ PlF P7K P8G P9D POA POK PlG P7L P8H P9E POB POL  ...
More
Class II Potential for the sterility barrier to be compromised. Covidien LP
Devices Covidien ROTICULATOR 30-4.8 Single Use Stapler REF# 017617 The RETICULA TOR TM Single Use Staplers have applications in abdominal, gynecologic and pediatric surgery for resection, transection, and creation of anastomosis LOT #'s BEGINNING WITH THE FOLLOWING LETTER/NUMBER COMBINATIONS P7E P8B P8L P9H POE PIB PIL P7F P8C P8M P9J POF PIC PlM P7G P8D P9A P9K POG PlD P2A P7H P8E P9B P9L POH PIE P2B0153X P7J P8F P9C P9M POJ PlF P7K P8G P9D POA POK PlG P7L P8H P9E POB POL  ...
More
Class II Potential for the sterility barrier to be compromised. Covidien LP
Devices Covidien ROTICULATOR 30-V3 Single Use Stapler REF# 017619 The RETICULA TOR TM Single Use Staplers have applications in abdominal, gynecologic and pediatric surgery for resection, transection, and creation of anastomosis LOT #'s BEGINNING WITH THE FOLLOWING LETTER/NUMBER COMBINATIONS P7E P8B P8L P9H POE PIB PIL P7F P8C P8M P9J POF PIC PlM P7G P8D P9A P9K POG PlD P2A P7H P8E P9B P9L POH PIE P2B0153X P7J P8F P9C P9M POJ PlF P7K P8G P9D POA POK PlG P7L P8H P9E POB POL  ...
More
Class II Potential for the sterility barrier to be compromised. Covidien LP
Devices Olympic Cool-Cap System is intended to provide treatment for neonatal hypoxic-ischemic encephalopathy (HIE). The Cool-Cap is indicated for use in full term infants (more than 36 week gestational age) with clinical evidence of moderate to severe HIE. The device provides selective head cooling with mild systemic hypothermia to prevent or reduce the severity of neurologic injury associated with HIE. It is a selective head cooling system for treatment of neonatal hypoxic-ischemic encephalopathy (HIE) in infants. A cooling water cap is placed on the infant's head and the body is warmed using radiant warmers. The Cool-Cap provides 72 hours of monitored cooling. The device is labeled in part: "***OLYMPIC COOL-CAP Cooling Unit***Model No.***Made in USA***Software in this product is Natus Medical Incorporated***" Cooling Serial Numbers: 1008; 1009; 1011; 1012; 1014; 1016; 1017; 1018; 1020; 1021; 1022; 1023; 1024; 1025; 1027; 1028; 1030; 1031; 1034; 1035; 1036; 1038; 1044; 1045; 1048; 1050; 1051; 1052; 1053; 1054; 1055; 1056; 1059; 1060; 1062; 1063; 1064; 1065; 1066; 1070; 1071; 1072; 1073; 1074; 1075; 1076; 1077; 1080;  ...
More
Class II Olympic Cool-Cap Cooling Module's power supply failed during treatment. The power supply failure can happen without prior indication and results in the unavailability of the system to begin or continue cooling treatment. Natus Medical Incorporated
Drugs Hands Down Medicated Lotion Soap, 1 gallon bottle, 4 gallons per case, Distributed by PCS Industries, Crestwood, IL, 60446 Lot #: 090204012 , 090303026 , 090508009 , 090604024 , 090725030 , 090829002, 091005017 , 091223002 , 100115022 , 100316005 , 100115022 , 100316005,100329004 , 100607017 , 100730001 , 100817014 , 100921018 , 101020009, 101208003 , 101218007 , 110405009 , (L)11053105 , (L)11062811 , (L)11081805, and (L)11091206 Class II Labeling: Presence of Undeclared Additive: Medicated lotion soap produced and distributed by the recalling firm contains the unapproved ingredient, Red Dye #15. This dye is not approved for use in food, drugs or cosmetics. Kutol Products Co Inc
Food Oskri, Peach Granola, Gluten Free, Nut Free, Dairy Free, Vegan, Halal, Kosher, Ingredients: Buck Wheat , Peaches 20% Sunflower Seeds , Apricots, Date Syrup, Chicory Root extract, Rice protein., NET WT 3.5oz (100) G., UPC 66616111743, Oskri, Lake Mills, Wisconsin 53551. Lot 75, P: 3/3/12, EXP: 9/9/13 Class I Oskri is recalling one lot of 3.53 oz bags of Peach Granola due to cashews being added to this product in error. Oskri Organics Corp.
Food Tiny IQF Oysters, 40pk/cs, 8oz. Lot#10997L Class II Ocean Group is recalling tiny IQF oysters, large IQF oysters, and half shell oysters from Korea because the products have been prepared, packed, or held under insanitary conditions whereby it may have become contaminated with filth, or whereby it may have been rendered injurious to health. Ocean Group Inc.
Food Large IQF Oysters, 6 x 4 lb/cs Lot#11801 Class II Ocean Group is recalling tiny IQF oysters, large IQF oysters, and half shell oysters from Korea because the products have been prepared, packed, or held under insanitary conditions whereby it may have become contaminated with filth, or whereby it may have been rendered injurious to health. Ocean Group Inc.
Food Half Shell Oysters, 144pc/cs Lot#209003, 208497, 209628, 209683 Class II Ocean Group is recalling tiny IQF oysters, large IQF oysters, and half shell oysters from Korea because the products have been prepared, packed, or held under insanitary conditions whereby it may have become contaminated with filth, or whereby it may have been rendered injurious to health. Ocean Group Inc.
Food KERRY, 4 CHEESE SEAS 30506103, CONTAINS MILK, Net Wt 50 Lb (22.68 Kg), Item Number 30506103.465 0502206602 Class II Kerry has decided to voluntarily recall its lactic acid containing products because they are contaminated with metal fragments. Kerry Foods
Food KERRY, WHITE CHEDDAR SNACK SEASONING, CONTAINS MILK, Item Number 6000654.01, Net Wt 50 Lb (22.68 Kg) 0426260104 Class II Kerry has decided to voluntarily recall its lactic acid containing products because they are contaminated with metal fragments. Kerry Foods
Food KERRY, CREAMY PARMESAN SEASONING, CONTAINS MILK, Item Number 62310.01, Net Wt 50 Lb (22.68 Kg) 0426276401 -0426276404 Class II Kerry has decided to voluntarily recall its lactic acid containing products because they are contaminated with metal fragments. Kerry Foods
Food KERRY, CHEDDAR CHEESE, CONTAINS MILK, 701183, R-SE-0056 , Item Number 701183.465, Net Wt 50 Lb (22.68 Kg) 0420276603 Class II Kerry has decided to voluntarily recall its lactic acid containing products because they are contaminated with metal fragments. Kerry Foods
Food KERRY, NACHO SEAS 0686, Contains Milk, Wheat, Net Wt 22.68 KG (50 lb), Item Number 10686.482 0412206603, 0503206601 Class II Kerry has decided to voluntarily recall its lactic acid containing products because they are contaminated with metal fragments. Kerry Foods
Food KERRY, CHEESE BLEND 77, 1150020, CONTAINS MILK AND SOY, Item # 17980.465, Net Wt 50 Lb (22.68 Kg) 0503206602 Class II Kerry has decided to voluntarily recall its lactic acid containing products because they are contaminated with metal fragments. Kerry Foods
Food KERRY, PARM. LING. 5734, SEA 5734, CONTAINS MILK, Item # 15734.607, , Net Wt 1000 Lb (453.556 Kg) 0409258004 Class II Kerry has decided to voluntarily recall its lactic acid containing products because they are contaminated with metal fragments. Kerry Foods
Food KERRY, LASAGNA SKLT SEAS 10078, SE10078, CONTAINS MILK, Item # I10078.859, Net Wt 1600 Lb (725.69Kg) 0423205406 Class II Kerry has decided to voluntarily recall its lactic acid containing products because they are contaminated with metal fragments. Kerry Foods
Food KERRY, CHEDDAR & SOUR CREAM 1037, CONTAINS MILK, Item # 717519.360, Net Wt 25 Lb (11.34Kg) 0402276402 0402276403 0402276404 0502276401 0502276402 0502276403 Class II Kerry has decided to voluntarily recall its lactic acid containing products because they are contaminated with metal fragments. Kerry Foods
Food KERRY, THREE CHEESE MINI SHELLS 10109, CH10109 , CONTAINS MILK, CH718592 Item Number I10109.859, Net Wt 1600 Lb (725.69 Kg) 0417258001 Class II Kerry has decided to voluntarily recall its lactic acid containing products because they are contaminated with metal fragments. Kerry Foods
Food KERRY, PARMESAN ASIAGO TYPE SEASONING, CONTAINS MILK, Item # 718622.465, Net Wt 50 Lb (22.68 Kg) 0509257903 Class II Kerry has decided to voluntarily recall its lactic acid containing products because they are contaminated with metal fragments. Kerry Foods
Food KERRY, CHEDDAR & SOUR CREAM 725775, CONTAINS MILK, Item # 725775.465, Net Wt 50 Lb (22.68 Kg) 0423223803 Class II Kerry has decided to voluntarily recall its lactic acid containing products because they are contaminated with metal fragments. Kerry Foods
Food KERRY, SOUR CR 7 CHIVES 718948, S37ASC, CONTAINS MILK, WHEAT, Item # 718948.465, Net Wt 50 Lb (22.68 Kg) 0430257902 Class II Kerry has decided to voluntarily recall its lactic acid containing products because they are contaminated with metal fragments. Kerry Foods
Food KERRY, THICK & CHEESY 0601, CH0601, CONTAINS MILK, Item Number 10601.859, Net Wt 1600 Lb (725.69 Kg) 0424205403 Class II Kerry has decided to voluntarily recall its lactic acid containing products because they are contaminated with metal fragments. Kerry Foods
Food Kerry, NO MSG CHED SC SEAS 01113, CONTAINS MILK, Item # 720061.465, Net Wt 50 Lb (22.68 Kg) 0511224104 Class II Kerry has decided to voluntarily recall its lactic acid containing products because they are contaminated with metal fragments. Kerry Foods
Food Kerry, PARMESAN BLEND 720068 CH720068, CONTAINS MILK, WHEAT, Item # 720068.607, Net Wt 1000 Lb (453.556 Kg) 0430258003 Class II Kerry has decided to voluntarily recall its lactic acid containing products because they are contaminated with metal fragments. Kerry Foods
Food Kerry, CREAMY PARMESAN SEAS S57CP, CONTAINS MILK, WHEAT, Item # 720104.465, Net Wt 50 Lb (22.68 Kg) 0410257905 Class II Kerry has decided to voluntarily recall its lactic acid containing products because they are contaminated with metal fragments. Kerry Foods
Food Kerry, CREAMY ITALIAN SEASONING S57CIT, CONTAINS MILK, Item # 720109.465, Net Wt 50 Lb (22.68 Kg) 0507257904 Class II Kerry has decided to voluntarily recall its lactic acid containing products because they are contaminated with metal fragments. Kerry Foods
Food KERRY, CHEDDAR BROCCOLI SEAS S25CBROC, CONTAINS MILK, Item # 720175.465, Net Wt 50 Lb (22.68 Kg) 0504257903 Class II Kerry has decided to voluntarily recall its lactic acid containing products because they are contaminated with metal fragments. Kerry Foods
Food KERRY, CREAMY GARLIC 720721 S25CG, CONTAINS MILK, SOY, WHEAT, Item # 720721.465, Net Wt 50 Lb (22.68 Kg) 0504257902 Class II Kerry has decided to voluntarily recall its lactic acid containing products because they are contaminated with metal fragments. Kerry Foods
Food KERRY, PARM GARLIC 720850 R-SE-0152, CONTAINS MILK, Item # 720850.470, Net Wt 50 Lb (22.68 Kg) 0510276401, 0426276602 Class II Kerry has decided to voluntarily recall its lactic acid containing products because they are contaminated with metal fragments. Kerry Foods
Food KERRY, BACON 7 RANCH SEAS 720943 SE720943, CONTAINS MILK, SOY, WHEAT, Item # 720943.859, Net Wt 1600 Lb (725.69 Kg) 0416258002 0504258001 0507258003 Class II Kerry has decided to voluntarily recall its lactic acid containing products because they are contaminated with metal fragments. Kerry Foods
Food KERRY, STROGANOFF SEAS 10079 SE10079, CONTAINS MILK, WHEAT, Item # I10079.859, Net Wt 1600 Lb (725.69 Kg) 0427205402 Class II Kerry has decided to voluntarily recall its lactic acid containing products because they are contaminated with metal fragments. Kerry Foods
Food KERRY, NACHO SEAS NAT, CONTAINS MILK, Item # 721108.465, Net Wt 50 Lb (22.68 Kg) 0504224104 Class II Kerry has decided to voluntarily recall its lactic acid containing products because they are contaminated with metal fragments. Kerry Foods
Food KERRY, WHITE CHEDDAR SEAS 10230 SE10230, CONTAINS MILK, WHEAT, Item # I10230.859, Net Wt 1600 Lb (725.69Kg) 0426258001 Class II Kerry has decided to voluntarily recall its lactic acid containing products because they are contaminated with metal fragments. Kerry Foods
Food KERRY, BUFFALO WING SEASONING , Item # I10256.465, Net Wt 50 Lb (22.68 Kg) 0507275301 Class II Kerry has decided to voluntarily recall its lactic acid containing products because they are contaminated with metal fragments. Kerry Foods
Food KERRY, CULTURED NF BUTTERMILK 986, CODE 031001.010, CONTAINS MILK, Item # I2868.465 , Net Wt 50 Lb (22.68 Kg) 0416205402 0417205401 0418205401 Class II Kerry has decided to voluntarily recall its lactic acid containing products because they are contaminated with metal fragments. Kerry Foods
Food KERRY, MELOBLEND 2237 code: d 1.29 edible, CONTAINS MILK, Item # I7097.465, Net Wt 50 Lb (22.68 Kg) 0418205403 Class II Kerry has decided to voluntarily recall its lactic acid containing products because they are contaminated with metal fragments. Kerry Foods
Food KERRY, BUTTERMILK 987 CONTAINS MILK, Item # I2993.465, Net Wt 50 Lb (22.68 Kg) 0419205403 Class II Kerry has decided to voluntarily recall its lactic acid containing products because they are contaminated with metal fragments. Kerry Foods
Food KERRY, AU GRATIN SEAS 722912, CONTAINS MILK, WHEAT, Item # 722912.465, Net Wt 50 Lb (22.68 Kg) 0502206603 Class II Kerry has decided to voluntarily recall its lactic acid containing products because they are contaminated with metal fragments. Kerry Foods
Food KERRY, ONION RING SEAS 18125 , CONTAINS MILK, Item # B18125.01, Net Wt 50 Lb (22.68 Kg) 0503224101 Class II Kerry has decided to voluntarily recall its lactic acid containing products because they are contaminated with metal fragments. Kerry Foods
Food KERRY, STROGANOFF SEAS 722920 SE722920, CONTAINS MILK, WHEAT, Item # 722920.859, Net Wt 1600 Lb (725.69 Kg) 0427205401 Class II Kerry has decided to voluntarily recall its lactic acid containing products because they are contaminated with metal fragments. Kerry Foods
Food KERRY, MAC 7 CHS SAUCE MIX 723357 CH723357, CONTAINS MILK, WHEAT, Item # 723357.859, Net Wt 1600 Lb (725.69 Kg) 0410258001 0416258001 Class II Kerry has decided to voluntarily recall its lactic acid containing products because they are contaminated with metal fragments. Kerry Foods
Food KERRY, BACON RANCH SEAS 723951 S57RB, CONTAINS MILK, Item # 723951.465, Net Wt 50 Lb (22.68 Kg) 0410257904 0508257901 Class II Kerry has decided to voluntarily recall its lactic acid containing products because they are contaminated with metal fragments. Kerry Foods
Food KERRY, SALSA FRESCA 725058, Item # 725058.465, Net Wt 50 Lb (22.68 Kg) 0426276601 Class II Kerry has decided to voluntarily recall its lactic acid containing products because they are contaminated with metal fragments. Kerry Foods
Food KERRY, ITALIAN PASTA SALAD SEASONING, Item # 725445.859, Net Wt 1600 Lb (725.69 Kg) 0430258002 Class II Kerry has decided to voluntarily recall its lactic acid containing products because they are contaminated with metal fragments. Kerry Foods
Food KERRY, GOLDEN CHEDDAR CHEESE 716932 , R-SE-0132, CONTAINS MILK, Item # 716932.465, Net Wt 50 Lb (22.68Kg) KERRY, R-SE-0132TM, CONTAINS MILK, Item # 716932.TM, Net Wt 50 Lb (22.68Kg) 0510276403 0424276403 Class II Kerry has decided to voluntarily recall its lactic acid containing products because they are contaminated with metal fragments. Kerry Foods
Food KERRY, SEA SALT & VINEGAR 722536 R-SE-0155, , Item # 722536.440, Net Wt 40 Lb (18.14 Kg) KERRY, R-SE-0155TM, , Item # 722536.TM, Net Wt 40 Lb (18.14 Kg) 0420276401 0420276402 0420276403 0426275303 0426275302 Class II Kerry has decided to voluntarily recall its lactic acid containing products because they are contaminated with metal fragments. Kerry Foods
Food KERRY, MOZZARELLA SESONING - NO PHSO, CONTAINS MILK, SOY, Item # I10187.465 , Net Wt 50 Lb (22.68Kg) 0502224108 Class II Kerry has decided to voluntarily recall its lactic acid containing products because they are contaminated with metal fragments. Kerry Foods
Food KERRY, ROASTED GARLIC SEAS 10112, S37RG2 , CONTAINS MILK, SOY, Item # I10112.465, Net Wt 50 Lb (22.68Kg) 0410206604 Class II Kerry has decided to voluntarily recall its lactic acid containing products because they are contaminated with metal fragments. Kerry Foods
Food KERRY, DOUBLE CHEESEBURGER SEAS 8917 , S20DC, CONTAINS MILK, WHEAT, Item #I8917.465, Net Wt 50 Lb (22.68Kg) 0417258002 Class II Kerry has decided to voluntarily recall its lactic acid containing products because they are contaminated with metal fragments. Kerry Foods
Food KERRY, SOUR CRM & CHIVES 0989 S37SCC, CONTAINS MILK, , Item #I0989.465 , Net Wt 50 Lb (22.68Kg) 0510257902 Class II Kerry has decided to voluntarily recall its lactic acid containing products because they are contaminated with metal fragments. Kerry Foods
Food KERRY, CHEESEBURGER SEAS 8543, S20C3, CONTAINS MILK,WHEAT , Item #I8543.465 , Net Wt 50 Lb (22.68Kg) 0430205403 Class II Kerry has decided to voluntarily recall its lactic acid containing products because they are contaminated with metal fragments. Kerry Foods
Food KERRY, KF PART # 117404 , CONTAINS MILK, Item #I10389.02 , Net Wt 50 Lb (22.68Kg) 0426223810 0420223803 Class II Kerry has decided to voluntarily recall its lactic acid containing products because they are contaminated with metal fragments. Kerry Foods
Food KERRY, KF # 11605R, CONTAINS MILK, Item #B18648.02 , Net Wt 50 Lb (22.68Kg) 0502224105 Class II Kerry has decided to voluntarily recall its lactic acid containing products because they are contaminated with metal fragments. Kerry Foods
Food KERRY, KF # 10987R, CONTAINS MILK, Item #B16903.01, Net Wt 50 Lb (22.68Kg) 0509224102 Class II Kerry has decided to voluntarily recall its lactic acid containing products because they are contaminated with metal fragments. Kerry Foods
Food KERRY, CHEDDAR BEER TYPE 725554 , CONTAINS MILK, Item #725554.465, Net Wt 50 Lb (22.68Kg) 0423223802 Class II Kerry has decided to voluntarily recall its lactic acid containing products because they are contaminated with metal fragments. Kerry Foods
Food KERRY, BATTER G3668, 1520374, CONTAINS MILK AND WHEAT, Item #G3668.MC1, Net Wt 50 Lb (22.68Kg) 0404216007 Class II Kerry has decided to voluntarily recall its lactic acid containing products because they are contaminated with metal fragments. Kerry Foods
Food KERRY, HOT CHEESE, SEAS, 04-20200, CONTAINS MILK , Item #I10185.465, Net Wt 50 Lb (22.68Kg) 0426258003 Class II Kerry has decided to voluntarily recall its lactic acid containing products because they are contaminated with metal fragments. Kerry Foods
Food KERRY, NACHO SEASONING 717379, 04-20200, CONTAINS MILK , SOY, Item # 717379.465, Net Wt 50 Lb (22.68Kg) 0425260117 Class II Kerry has decided to voluntarily recall its lactic acid containing products because they are contaminated with metal fragments. Kerry Foods
Food KERRY, CHEESE BLEND 862B , CONTAINS MILK Item # I2065.465, Net Wt 50 Lb (22.68Kg) 0426257901 Class II Kerry has decided to voluntarily recall its lactic acid containing products because they are contaminated with metal fragments. Kerry Foods
Food KERRY, CHEESE SEASONING 15704, CONTAINS MILK, Item # B15704.01, Net Wt 50 Lb (22.68Kg) 0504224103 0504224102 Class II Kerry has decided to voluntarily recall its lactic acid containing products because they are contaminated with metal fragments. Kerry Foods
Food KERRY, CHEESY CHEDDAR SEAS I10103, CONTAINS MILK, SOY, Item # I10103.465, Net Wt 50 Lb (22.68Kg) 0511223806 Class II Kerry has decided to voluntarily recall its lactic acid containing products because they are contaminated with metal fragments. Kerry Foods
Food KERRY, JALAPENO CHEDDAR 16975, GCAS# 95546689, CONTAINS MILK, Item # B16975.01, Net Wt 50 Lb (22.68Kg) 0430223802 0430223803 Class II Kerry has decided to voluntarily recall its lactic acid containing products because they are contaminated with metal fragments. Kerry Foods
Food KERRY, CHEZ-TONE 6313, QO-05424 / QO-2200542400, CONTAINS MILK, Item # I6313.465, Net Wt 50 Lb (22.68Kg) 0410206601 Class II Kerry has decided to voluntarily recall its lactic acid containing products because they are contaminated with metal fragments. Kerry Foods
Food KERRY, MELOBLEND 737, CODE:QO-05358, CONTAINS MILK, Item # I7126.465, Net Wt 50 Lb (22.68Kg) 0416205401 Class II Kerry has decided to voluntarily recall its lactic acid containing products because they are contaminated with metal fragments. Kerry Foods
Food KERRY, PL BROC & CHEESE SEAS 8893 , CONTAINS MILK, WHEAT, Item # I8893.465, Net Wt 50 Lb (22.68Kg) 0419258001 Class II Kerry has decided to voluntarily recall its lactic acid containing products because they are contaminated with metal fragments. Kerry Foods
Food KERRY, MELOBLEND 1048, 95317, CONTAINS MILK, Item # I7067.465, Net Wt 50 Lb (22.68Kg) 0420205403 Class II Kerry has decided to voluntarily recall its lactic acid containing products because they are contaminated with metal fragments. Kerry Foods
Food KERRY, PARMESAN AND SUNDRIED TOMATO SEASONING, CONTAINS MILK, Item # B18122.01, Net Wt 50 Lb (22.68Kg) 0508276601 Class II Kerry has decided to voluntarily recall its lactic acid containing products because they are contaminated with metal fragments. Kerry Foods
Food KERRY, HOT BUFFALO WINGS PRETZEL SEAS 173211, Item # B16413.01, Net Wt 44.5 Lb (20.18 kg) 0424223803 0424223804 0502223801 0502223802 Class II Kerry has decided to voluntarily recall its lactic acid containing products because they are contaminated with metal fragments. Kerry Foods
Food KERRY, SOUR CREAM AND ONION 10286, CONTAINS MILK, Item # I10286.465, Net Wt 50 Lb (22.68 Kg) 0430275306 0430275307 0430275304 0430275305 0430275308 0430275301 0430275302 Class II Kerry has decided to voluntarily recall its lactic acid containing products because they are contaminated with metal fragments. Kerry Foods
Food KERRY, PARM GARLIC SEAS 721221, CONTAINS MILK, Item # 721221.399 & 721221.398 , Net Wt 50 Lb (22.68 Kg) 0426223807 Class II Kerry has decided to voluntarily recall its lactic acid containing products because they are contaminated with metal fragments. Kerry Foods
Devices Philips Multi Diagnost Eleva II with swivel cable Product Codes; 708032, 708036 Multi Diagnost Eleva with FlatDetector with swivel cable Product Codes: 708034, 708037 This Philips MultiDiagnost Eleva system is intended to be used as a multifunctional/ universal system. General R/F, performed along with more specialized interventional applications. This includes the following general areas: Digestive system Skeletal system Urinary system Reproductive system Respiratory system Circulatory system Various . Arthrograms . Myelograms . Facet joint injections . Discography SialographyFluoroscopy, Radiography and Angiography Units with cable swivel delivered from 2007 Class II MultiDiagnost Eleva X--Ray system may have damage to System Cables from repeated movement Philips Healthcare Inc.
Drugs Magnesium Sulfate in Water for Injection, 40 mg/mL (0.325 mEq Mg++/mL), 2 g total, 50 mL Flexible Container, Rx only, Hospira, Inc., Lake Forest, IL 60045; NDC 0409-6729-24. Lot #: 04510KL*, Exp 01OCT2012; *lot number may have 01 or 02 following it Class III Superpotent (Single Ingredient) Drug: Above specification assay results for percentage of magnesium sulfate. Hospira, Inc.
Devices Peak SE Primer Kits (4 syringes per kit) manufactured by Ultradent Products, Inc, South Jordan, UT, Self Etch Primer. The product is contained within prefilled, labeled syringes in a transparent plastic container identified with an aqua, red, orange, blue and black label with black and blue print writing. Product code: 5135, 872.3200 KLE, liquid and powder mixture is a syringe-in-a-syringe delivery system. The product is used for most bonding needs in restorative dentistry. Bonds chemical cure luting and chemical cure composites, namely PermaFlo DC. Peak SE does not require a separate etching step for quality adhesion. Peak SE is also conducive for bonding to: Dentin and enamel, porcelain, metal and composite. Lot number: B6Z4K. Class II Ultradent is recalling lot B6Z4K of Peak SE Primer as a result of a field complaint, dated May 10, 2012, stating that a syringe of Peak SE Primer was mislabeled as Peak LC Bond Resin. These products are used by Dental professionals for bonding needs in restorative dental procedures. Ultradent Products, Inc.
Devices Arrow International, Inc. 7FR 3-Lumen Arrowg+ard Blue Plus(R) Pressure Injectable Central Venous Catheter - Catalog number CDC-42703-XP1A The multiple-lumen pressure injectable catheter permits venous access to central circulation and injection of contrast media. The ARROWg+ard(R) antimicrobial surface is intended to provide protection against catheter-related infections. Lot number RF2033361 Class II Arrow is recalling the product due to the possibility of voids in the catheter hub which could lead to an interlumen crossover. Arrow International Inc
Devices seprafilm® Procedure Pack ADHESION BARRIER Re-order Number: 5086-02 Product Usage: Seprafilm Adhesion Barrier is indicated for use in patients undergoing abdominal or pelvic laparotomy as an adjunct intended to reduce the incidence, extent and severity of postoperative adhesions between the abdominal wall and the underlying viscera such as omentum, small bowel, bladder, and stomach, and between the uterus and surrounding structures such as tubes and ovaries, large bowel, and bladder. Lot numbers: 11NP620 Exp. 2014 - 09; 11NP630 Exp 2014 - 10; and 11NP649 Exp 2014- 11; 11NP704 Exp 2014 - 11 Class II Sterility of product may be compromised due to packaging defect Genzyme Corporation
Devices seprafilm® Single Site ADHESION BARRIER Re-order Number: 6641-01 Product Usage: Seprafilm Adhesion Barrier is indicated for use in patients undergoing abdominal or pelvic laparotomy as an adjunct intended to reduce the incidence, extent and severity of postoperative adhesions between the abdominal wall and the underlying viscera such as omentum, small bowel, bladder, and stomach, and between the uterus and surrounding structures such as tubes and ovaries, large bowel, and bladder. Lot number: 11NP685 . Exp 2014- 11 Class II Sterility of product may be compromised due to packaging defect Genzyme Corporation
Devices Stryker Howmedica Osteonics Accolade Offset Rasp Handle Howmedica Osteonics Corp. 325 Corporate Drive, Mahwah, NJ 07430 USA Stryker France ZAC Satolas Green Pusignan Av de Satolas Green 69881 Meyzieu Cedex France Single offset rasp handle designed to mate to the Accolade femoral broaches to prepare the femoral canal in a total hip anthroplasty using the Accolade Hip System. The offset rasp handle incorporates an offset angle designed to minimize interference with surrounding soft tissue. 510K exempt Catalog Number 1020-1400 Lot Code P5E93 Class II Stryker Orthopaedics has become aware of the potential for the above noted Accolade Rasp Handle Assembly to fracture upon use. Stryker Howmedica Osteonics Corp.
Drugs Lipitor (Atorvastatin calcium); 40 mg, 30 TABLETS, Rx only, Repacked & distributed: Physicians Total Care, Inc., Tulsa OK 74146, NDC 54868-4229-0 Lots 6284, 60DI, 61AA. Class II Chemical Contamination: Complaints of an uncharacteristic odor identified as 2,4,6 tribromoanisole. Physicians Total Care, Inc.
Food Frozen Oysters: 1) CHORIPDONG) FROZEN OYSTER, IQF 8OZ*40; 2) CJ FOOD, INC.)FROZEN OYSTER 8oz*40; Not for Retail Sale, Must be fully cooked before serving. Distributed by CJ Foods, Inc., Commerce, CA; 3) JAYONE FOODS, INC.) FROZEN OYSTER 8 oz*40, IQF, Distributed by Jayone Foods, Inc.., Paramount, CA 92723 Product of Korea 1) Item number 3137810; 2) Item number 2237840; 3) Item number 36037800 Class II The product has been prepared, packed, or held under insanitary conditions whereby it may have become contaminated with filth, or whereby it may have been rendered injurious to health. Woosung America Corp.
Food HONG CHANG)OYSTER MEAT 8 oz*40 Item number 2137845 Class II The product has been prepared, packed, or held under insanitary conditions whereby it may have become contaminated with filth, or whereby it may have been rendered injurious to health. Woosung America Corp.
Food OCEAN GREEN)OYSTER LARGE 5lb*6, IQF Imported by: J & S Group 2535E 12th St. #B Los Angeles, CA 90021 Item number oys0070 Class II The product has been prepared, packed, or held under insanitary conditions whereby it may have become contaminated with filth, or whereby it may have been rendered injurious to health. Woosung America Corp.
Food PACIFIC GIANT) OYSTERS,IQF,KOREA 8 oz*40 Imported by Pacific Giant, Vernon, CA 90058 Product of Korea Item number 6537880 Class II The product has been prepared, packed, or held under insanitary conditions whereby it may have become contaminated with filth, or whereby it may have been rendered injurious to health. Woosung America Corp.
Food popchips® Cheddar Potato, Popped Chip Snack, 0.8 oz, UPC 0 82666 78800 3 Lot MAY2613, MAY2913TM Class II The firm received ingredient lactic acid from Kerry Ingredients and Flavors that may potentially contain metal fragments. Sonora Mills Foods
Food popchips® Sea Salt & Vinegar, Potato Popped Chip Snack, 0.4 oz (UPC 0 82666 76550 9), 0.8 oz (UPC 0 82666 75500 5), 3 oz (UPC 0 82666 70050 0), 85 g (UPC 0 82666 71240 4 and 0 82666 71240 4) 0.4oz: MAY2113; 0.8 oz: Lot MAY1613, MAY2013, MAY2113TM, MAY2613; 3 oz: MAY0313, MAY0813, MAY0913, MAY1013LY, MAY1513, MAY1613, MAY2113, MAY2113TM; 85g: Lot 13MA23TM and 13MA08 Class II The firm received ingredient lactic acid from Kerry Ingredients and Flavors that may potentially contain metal fragments. Sonora Mills Foods
Food Cheddar Mini Rice Snacks under the following brand names: Fred Meyer, 3 oz, UPC 0 11110 90004 3; Kroger, 3 oz, UPC 0 11110 35789 2; Ralphs, 3 oz, UPC 0 11110 91220 9; Safeway, 3 oz. UPC 0 21130 29808 2; Lot FEB 19 13 Class II The firm received ingredient lactic acid from Kerry Ingredients and Flavors that may potentially contain metal fragments. Sonora Mills Foods
Food Reese Colossal Smoked Oysters. Distributed by: World Finer Foods, Inc. Bloomfield, NJ 07003 USA. Product of Korea. UPC 70670-00576 UPC 70670-00576; OYSO MY-7 1520; OYSO MY-7 1521; OYSO My-7 1617; OYSO MY-7 1618; OYSO MY-7 1620. Class III According to information published by the FDA: Because of inadequate sanitation controls, the molluscan shellfish harvested from Korean waters may have been exposed to human fecal waste and have the potential to be contaminated with a norovirus. World Finer Foods, Inc.
Food Reese Medium Smoked Oysters. Distributed by: World Finer Foods, Inc. Bloomfield, NJ 07003 USA. Product of Korea. UPC 70670-00600. UPC 70670-00600; OYSO MY-7 1523; OYSO MY-7 1521; OYSO My-7 1618; OYSO; OYSO MY-7 1621. Class III According to information published by the FDA: Because of inadequate sanitation controls, the molluscan shellfish harvested from Korean waters may have been exposed to human fecal waste and have the potential to be contaminated with a norovirus. World Finer Foods, Inc.
Food Reese Petite Smoked Oysters. Distributed by: World Finer Foods, Inc. Bloomfield, NJ 07003 USA. Product of Korea, UPC 70670-00575. UPC 70670-00575; OYSO SY-7 1524; OYSO SY-7 1521; OYSO SY-7 1617; OYSO SY-7 1621. Class III According to information published by the FDA: Because of inadequate sanitation controls, the molluscan shellfish harvested from Korean waters may have been exposed to human fecal waste and have the potential to be contaminated with a norovirus. World Finer Foods, Inc.
Food Smoked Oysters In cottonseed oil sold under the following brand names: 1) Fredmeyer Smoked Oysters In cottonseed oil Net Wt 3.75 oz (106 g) Distributed by Inter-American Products, Cincinnati, Ohio 45202, Product of Korea; 2) Ralph's Smoked Oysters In Cottonseed Oil Distributed by Inter-American Products Cincinnati, Ohio 45202 Product of Korea; 3) Kroger Smoked Oysters In cottonseed oil , Distributed by the Kroger Co., Cincinnati, OH 45202, Product of Korea All lots and UPCs Best by date 2013 Class III Inspectional evidence and sample analyses as well as reports of food borne illness outbreaks due to norovirus have led FDA to believe that Korean molluscan shellfish and products containing KMS as ingredients are adulterated under Section 40(a)(4) in that they were prepared and held under insanitary conditions, whereby they may have become contaminated with filth or whereby they may have been rendered injurious to health namely from exposure to human fecal waste and contamination with norovirus. Camerican International
Food Whole Oysters in Water under the following brand names: 1) Ralph's Whole Oysters in Water, Net Wt. 8 OZ (226 g) Distributed by Inter-American Products, Cincinnati, Ohio 45202, Product of Korea; 2) Kroger Whole Oysters in Water Net Wt. 8 OZ (226g) Distributed by the Kroger Co., Cincinnati, Ohio 45202 All lots and UPCs Class III Inspectional evidence and sample analyses as well as reports of food borne illness outbreaks due to norovirus have led FDA to believe that Korean molluscan shellfish and products containing KMS as ingredients are adulterated under Section 40(a)(4) in that they were prepared and held under insanitary conditions, whereby they may have become contaminated with filth or whereby they may have been rendered injurious to health namely from exposure to human fecal waste and contamination with norovirus. Camerican International
Food Northern Catch Fancy Whole Oysters Net Wt. 8 OZ (227g) Distributed by the Aldi Inc., Batavia, IL 60510 Product of Korea OBYL MY7 0427, OBYL MY7 0503, OBYL MY7 0507, OBYL MY7 0512, OBYL MY7 0515, OBYL MY7 0518, OBYL MY7 0519, OBYL MY7 0521, OBYL MY7  ...
More
Class III Inspectional evidence and sample analyses as well as reports of food borne illness outbreaks due to norovirus have led FDA to believe that Korean molluscan shellfish and products containing KMS as ingredients are adulterated under Section 40(a)(4) in that they were prepared and held under insanitary conditions, whereby they may have become contaminated with filth or whereby they may have been rendered injurious to health namely from exposure to human fecal waste and contamination with norovirus. Camerican International
Food Tempeh Starter Yeast, Rhizopus Oligosporus cultures, soybean rice flour, Original, packaged in clear plastic packages in 30gm, 50gm, 250 gm, and 1000 gm sizes and labeled in part ***Indonesianfoodmart.com*** Product is not coded Class I Imported food product tested positive for Salmonella. Indonesian Food Mart
Food Tempeh Super Starter Yeast, Rhizopus Oligosporus cultures, soybean rice flour, packaged in clear plastic packages in 30 gm, 50 gm, 250 gm, and 1000 gm sizes and labeled in part ***Indonesianfoodmart.com*** Product is not coded Class I Imported food product tested positive for Salmonella. Indonesian Food Mart
Food Oyster Frozen Half Shell; 144 Pc/CS Processed by: Dai One Food Co., LTD #150 Jun-RI, Sanyang-UP Tongyeong-City Kyungsangnam-DO. to: Khee Trading, Vernon, CA 90058. Code number OYS0300 Class II The product has been prepared, packed, or held under insanitary conditions whereby it may have become contaminated with filth, or whereby it may have been rendered injurious to health. True World Foods San Francisco LLC.
Food Frozen Oyster Meat IQF (Z4) 4 lb box Packed by Dong Won Mul San Co. Tongyeong-City, Gyeongsangnam-Do. Imported by Ayana Group, Inc. Washington, CA Code number OYS0550 Class II The product has been prepared, packed, or held under insanitary conditions whereby it may have become contaminated with filth, or whereby it may have been rendered injurious to health. True World Foods San Francisco LLC.
Food Breaded Oyster Large Size Code number OYS0800 Class II The product has been prepared, packed, or held under insanitary conditions whereby it may have become contaminated with filth, or whereby it may have been rendered injurious to health. True World Foods San Francisco LLC.
Food Granadaisa whole Oysters, Net WT. 8 oz (225 grams); Packed For King Seafoods Inc. PO BOX 107, Mount Holly, NJ USA 08060 Product of Korea Farm Raised, UPC 719882002049. no coding Class III The US FDA has removed all Korean certified shippers of molluscan shellfish (oysters, clams, mussels and scallops) from the Interstate Shellfish Shippers List (ICSSL), following a comprehensive FDA evaluation that determined that the Korean Shellfish Sanitation Program (KSSP) no longer meets the sanitation controls spelled out under the National Shellfish Sanitation Program. King Seafoods Inc.
Food Frozen Korean Oyster Meat I.Q.F.: , 1) 40x8oz., UPC 19964 30091; 2) 1x25lbs, .; 3) 5x4lbs.UPC 19964 30092 1) lot#138338P; 2) lot#138339-P; 3) lot #138340-P Class II Red Chambers is recalling Dai One Food Oyster IQF 4lbs, 25 lbs, and 8 oz because the products have been prepared, packed, or held under insanitary conditions whereby it may have been contaminated with filth, or whereby it may have been rendered injurious to health. Red Chamber Company
Show all Code Info
-
-