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U.S. Department of Health and Human Services

Enforcement Report - Week of October 7, 2014

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Product Type Product Description Code Info Classification Reason for Recall Recalling Firm
Drugs All sterile drugs compounded between 2/21/14 and 2/24/14. Expiration dates between 3/5/14 and 3/10/14. Class II Lack of Assurance of Sterility: All compounded products. New England Home Therapies, Inc
Drugs Zoledronic Acid Injection 5 mg per 100 mL (0.05 mg/mL), 100 mL single-use bag packaged in a foil overwrap, Rx only, Sterile, For Intravenous Infusion, Mfd. for Sagent Pharmaceuticals Schaumburg, IL ---- NDC 25021-830-82 NDC 25021-830-82; Lot Numbers and Expiration Dates: Lot 30076, Expires 01/2015; Lot 30077, Expires 01/2015. Class II Lack of Assurance of Sterility; leaking of premix bags Sagent Pharmaceuticals Inc
Devices Verigene BC-GP Kit (Catalog number 20-005-018); 1) 20 Verigene BC-GP Test Cartridges; are qualitative multiplexed in vitro diagnostic tests for simultaneous detection and identification of selected gram-positive (BC-GP) and gram-negative (BC-GN) bacteria and resistance markers. Part Number: 20-009-018; Lot Numbers: 051713018B, 052413018C Class II There is a specific Extraction Tray lot containing Tips that may slightly increase the occurrence of Process SP Processing Error when used due to the Processor SP experiencing difficulty releasing the Tip to the final location in the Tip Assembly. The difficult releasing the Tip can result in a Processing Error and occasionally the Tip to be dropped into the Processor SP. Nanosphere, Inc.
Devices Verigene BC-GN Kit (Catalog number 20-005-021); 1) 20 Verigene BC-GN Test Cartridges; are qualitative multiplexed in vitro diagnostic tests for simultaneous detection and identification of selected gram-positive (BC-GP) and gram-negative (BC-GN) bacteria and resistance markers. Part Number: 20-009-021; Lot Numbers: 052113021C Class II There is a specific Extraction Tray lot containing Tips that may slightly increase the occurrence of Process SP Processing Error when used due to the Processor SP experiencing difficulty releasing the Tip to the final location in the Tip Assembly. The difficult releasing the Tip can result in a Processing Error and occasionally the Tip to be dropped into the Processor SP. Nanosphere, Inc.
Drugs Black Ant, 2800 mg, four capsules per box, Manufacturer Qinghai Baojiantang Pharmaceutical Co., Ltd. All lots Class I Marketed Without an Approved NDA/ANDA: Eugene FDA laboratory analyses determined they contain undeclared sildenafil. Eugene Oregon, Inc.
Drugs MOJO RISEN, 650 mg, 2 capsule per pouch, Distributed by: Mojo Risen, LLC, Springville, UT 84663 All lots Class I Marketed Without an Approved NDA/ANDA: Eugene FDA laboratory analyses determined they contain undeclared sildenafil. Eugene Oregon, Inc.
Drugs AFRICAN BLACK ANT, 2800 mg, 6 capsules per box, produced by: Qinghan Hongwei Bioengineering Company, No. 158, Renmin Road, Xining City. All lots Class I Marketed Without an Approved NDA/ANDA: Eugene FDA laboratory analyses determined they contain undeclared sildenafil. Eugene Oregon, Inc.
Devices CelluTome Epidermal Harvesting System Part number CT-H25 or Part Number CT-H50 Part number CT-H25 with the following lot numbers: 3244680000, 3446210000, 3246280000, 3246480000, 3246490000, 3246970000, 3247020000, 3247030000, 3247130000, 3247440000, 3247670000, 3247680000, 3247980000, 3248070000, 3248200000, 3248300000, 3249120000, 3249130000, 3249140000, 3249150000, 3249160000. Part number CT-H50 with the following lot numbers: 324782, 324796, 324797, 3245120000, 3245670000, 3245680000, 3246270000, 3246490000, 3246690000, 3246700000, 3246940000, 3246980000, 3247140000, 3247160000,  ...
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Class II Blade can shift during shipping which makes the product ineffective. KCI USA, Inc.
Food BAR HARBOR JAM COMPANY Maine Wild Blueberry Pancake Mix; Net Wt. 1 lb 6 oz (624 g) UPC Code: 892845001 607 Class II Label does not declare wheat. Bar Harbor Jam Company
Food BAR HARBOR JAM COMPANY Maine Wild Blueberry Muffin Mix; Net Wt. 1 lb 6 oz (624 g) UPC Code: 892845001 614 Class II Label does not declare wheat. Bar Harbor Jam Company
Food BAR HARBOR JAM COMPANY Maine Old Fashioned Popover Mix; Net Wt 1 lb 5 oz (624g) UPC Code: 892845001621 Class II Label does not declare wheat. Bar Harbor Jam Company
Drugs Marcaine (bupivacaine HCl) injection, USP, 0.5%, Preservative-Free, 30 mL (150 mg) Single-dose Vial, Rx only, Hospira, Inc., Lake Forest, IL 60045 NDC 0409-1560-29 Lot # 33-545-DD, Exp. 09/15 Class I Presence of Particulate Matter: Confirmed customer complaint of discolored solution with visible metal particles embedded in the glass vial and visible in the solution. Hospira Inc.
Devices Reusable laparoscopic instruments are packaged as non-sterile. Cleaning and sterilization of devices must occur prior to use. The instruments are intended to be used by qualified physicians to provide access, illumination and visualization of internal structures and for manipulating soft tissue (grasping, cutting, coagulating, dissecting and suturing) in a wide variety of diagnostic and therapeutic laparoscopic/ urologic closed and minimally invasive procedures. It is inserted via a trocar sleeve and is used to prepare, coagulate and cut tissue. 1) Instrumed Item No.: 250-08800; Adler Instrument Company Catalog Code: 70-0300; Lot Number: 070113; 2) Instrumed Item No.: 250-08860 ; Adler Instrument Company Catalog Code: 70-0319; Lot Number: 030312, 070411; 3) Instrumed Item No.: 250-08930; Adler Instrument Company Catalog Code: 70-0318; Lot Number: 010113, 020113, 030112, 050412, 060413, 070512, 090213,  ...
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Class II Additional caution statements have been added to the Instruction For Use for monopolar electrodes. The additional caution statements are as follows: 1) "To avoid tissue carbonation, the operation voltage of the HF generator must not exceed 650 peak voltage (Vp) for all monopolar electrodes." and 2) "For all monopolar electrodes, the useful life of this product is less than or equal to 50 cycles and less than or equal to 2 years." Instrumed International, Inc.
Devices Reusable laparoscopic instruments are packaged as non-sterile. Cleaning and sterilization of devices must occur prior to use. The instruments are intended to be used by qualified physicians to provide access, illumination and visualization of internal structures and for manipulating soft tissue (grasping, cutting, coagulating, dissecting and suturing) in a wide variety of diagnostic and therapeutic laparoscopic/ urologic closed and minimally invasive procedures. It is inserted via a trocar sleeve and is used to prepare, coagulate and cut tissue. 1) Instrumed Item No.: 250-08930; Ambler Surgical Corporation Catalog Code: J647-6; Lot Number: 060412; Class II Additional caution statements have been added to the Instruction For Use for monopolar electrodes. The additional caution statements are as follows: 1) "To avoid tissue carbonation, the operation voltage of the HF generator must not exceed 650 peak voltage (Vp) for all monopolar electrodes." and 2) "For all monopolar electrodes, the useful life of this product is less than or equal to 50 cycles and less than or equal to 2 years." Instrumed International, Inc.
Devices Reusable laparoscopic instruments are packaged as non-sterile. Cleaning and sterilization of devices must occur prior to use. The instruments are intended to be used by qualified physicians to provide access, illumination and visualization of internal structures and for manipulating soft tissue (grasping, cutting, coagulating, dissecting and suturing) in a wide variety of diagnostic and therapeutic laparoscopic/ urologic closed and minimally invasive procedures. It is inserted via a trocar sleeve and is used to prepare, coagulate and cut tissue. 1) Instrumed Item No.: 250-08680; Boss Instruments Catalog Code: 35-8015; Lot Number: 030411, 100110, 110210; 2) Instrumed Item No.: 250-08700; Boss Instruments Catalog Code: 35-8016; Lot Number: 030111; 3) Instrumed Item No.: 250-08700; Boss Instruments Catalog Code: 35-8016; Lot Number: 30111; 4) Instrumed Item No.: 250-08760; Boss Instruments Catalog Code:  ...
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Class II Additional caution statements have been added to the Instruction For Use for monopolar electrodes. The additional caution statements are as follows: 1) "To avoid tissue carbonation, the operation voltage of the HF generator must not exceed 650 peak voltage (Vp) for all monopolar electrodes." and 2) "For all monopolar electrodes, the useful life of this product is less than or equal to 50 cycles and less than or equal to 2 years." Instrumed International, Inc.
Devices Reusable laparoscopic instruments are packaged as non-sterile. Cleaning and sterilization of devices must occur prior to use. The instruments are intended to be used by qualified physicians to provide access, illumination and visualization of internal structures and for manipulating soft tissue (grasping, cutting, coagulating, dissecting and suturing) in a wide variety of diagnostic and therapeutic laparoscopic/ urologic closed and minimally invasive procedures. It is inserted via a trocar sleeve and is used to prepare, coagulate and cut tissue. 1) Instrumed Item No.: 250-08570; CareFusion Catalog Code: VM46-9112-1; Lot Number: 010111; 2) Instrumed Item No.: 250-08600; CareFusion Catalog Code: LA8523 ; Lot Number: 070211, 070213, 090412; 3) Instrumed Item No.: 250-08610; CareFusion Catalog Code: LA8523-45; Lot Number: 042011, 062209; 4) Instrumed Item No.: 250-08620; CareFusion Catalog Code: LA8515; Lot Number:  ...
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Class II Additional caution statements have been added to the Instruction For Use for monopolar electrodes. The additional caution statements are as follows: 1) "To avoid tissue carbonation, the operation voltage of the HF generator must not exceed 650 peak voltage (Vp) for all monopolar electrodes." and 2) "For all monopolar electrodes, the useful life of this product is less than or equal to 50 cycles and less than or equal to 2 years." Instrumed International, Inc.
Devices Reusable laparoscopic instruments are packaged as non-sterile. Cleaning and sterilization of devices must occur prior to use. The instruments are intended to be used by qualified physicians to provide access, illumination and visualization of internal structures and for manipulating soft tissue (grasping, cutting, coagulating, dissecting and suturing) in a wide variety of diagnostic and therapeutic laparoscopic/ urologic closed and minimally invasive procedures. It is inserted via a trocar sleeve and is used to prepare, coagulate and cut tissue. 1) Instrumed Item No.: 250-08930; Pilling Weck Inc. / Teleflex Medical Catalog Code: 728163; Lot Number: 66745 Class II Additional caution statements have been added to the Instruction For Use for monopolar electrodes. The additional caution statements are as follows: 1) "To avoid tissue carbonation, the operation voltage of the HF generator must not exceed 650 peak voltage (Vp) for all monopolar electrodes." and 2) "For all monopolar electrodes, the useful life of this product is less than or equal to 50 cycles and less than or equal to 2 years." Instrumed International, Inc.
Devices Reusable laparoscopic instruments are packaged as non-sterile. Cleaning and sterilization of devices must occur prior to use. The instruments are intended to be used by qualified physicians to provide access, illumination and visualization of internal structures and for manipulating soft tissue (grasping, cutting, coagulating, dissecting and suturing) in a wide variety of diagnostic and therapeutic laparoscopic/ urologic closed and minimally invasive procedures. It is inserted via a trocar sleeve and is used to prepare, coagulate and cut tissue. 1) Instrumed Item No.: 250-08930; Specialty Care Catalog Code: 30-92221; Lot Number: 040413 Class II Additional caution statements have been added to the Instruction For Use for monopolar electrodes. The additional caution statements are as follows: 1) "To avoid tissue carbonation, the operation voltage of the HF generator must not exceed 650 peak voltage (Vp) for all monopolar electrodes." and 2) "For all monopolar electrodes, the useful life of this product is less than or equal to 50 cycles and less than or equal to 2 years." Instrumed International, Inc.
Devices Reusable laparoscopic instruments are packaged as non-sterile. Cleaning and sterilization of devices must occur prior to use. The instruments are intended to be used by qualified physicians to provide access, illumination and visualization of internal structures and for manipulating soft tissue (grasping, cutting, coagulating, dissecting and suturing) in a wide variety of diagnostic and therapeutic laparoscopic/ urologic closed and minimally invasive procedures. It is inserted via a trocar sleeve and is used to prepare, coagulate and cut tissue. 1) Instrumed Item No.: 250-08860; Symmetry Surgical Inc.  ...
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Class II Additional caution statements have been added to the Instruction For Use for monopolar electrodes. The additional caution statements are as follows: 1) "To avoid tissue carbonation, the operation voltage of the HF generator must not exceed 650 peak voltage (Vp) for all monopolar electrodes." and 2) "For all monopolar electrodes, the useful life of this product is less than or equal to 50 cycles and less than or equal to 2 years." Instrumed International, Inc.
Devices Reusable laparoscopic instruments are packaged as non-sterile. Cleaning and sterilization of devices must occur prior to use. The instruments are intended to be used by qualified physicians to provide access, illumination and visualization of internal structures and for manipulating soft tissue (grasping, cutting, coagulating, dissecting and suturing) in a wide variety of diagnostic and therapeutic laparoscopic/ urologic closed and minimally invasive procedures. It is inserted via a trocar sleeve and is used to prepare, coagulate and cut tissue. 1) Instrumed Item No.: 250-09010; Phoenix Instruments Catalog Code: 190-9523; Lot Number: 070411; 2) Instrumed Item No.: 250-09040; Phoenix Instruments Catalog Code: 190-9527; Lot Numbers: 010211, 040411 Class II Additional caution statements have been added to the Instruction For Use for monopolar electrodes. The additional caution statements are as follows: 1) "To avoid tissue carbonation, the operation voltage of the HF generator must not exceed 650 peak voltage (Vp) for all monopolar electrodes." and 2) "For all monopolar electrodes, the useful life of this product is less than or equal to 50 cycles and less than or equal to 2 years." Instrumed International, Inc.
Devices Reusable laparoscopic instruments are packaged as non-sterile. Cleaning and sterilization of devices must occur prior to use. The instruments are intended to be used by qualified physicians to provide access, illumination and visualization of internal structures and for manipulating soft tissue (grasping, cutting, coagulating, dissecting and suturing) in a wide variety of diagnostic and therapeutic laparoscopic/ urologic closed and minimally invasive procedures. It is inserted via a trocar sleeve and is used to prepare, coagulate and cut tissue. 1) Instrumed Item No.: 250-08930; Surgical Direct Catalog  ...
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Class II Additional caution statements have been added to the Instruction For Use for monopolar electrodes. The additional caution statements are as follows: 1) "To avoid tissue carbonation, the operation voltage of the HF generator must not exceed 650 peak voltage (Vp) for all monopolar electrodes." and 2) "For all monopolar electrodes, the useful life of this product is less than or equal to 50 cycles and less than or equal to 2 years." Instrumed International, Inc.
Devices Reusable laparoscopic instruments are packaged as non-sterile. Cleaning and sterilization of devices must occur prior to use. The instruments are intended to be used by qualified physicians to provide access, illumination and visualization of internal structures and for manipulating soft tissue (grasping, cutting, coagulating, dissecting and suturing) in a wide variety of diagnostic and therapeutic laparoscopic/ urologic closed and minimally invasive procedures. It is inserted via a trocar sleeve and is used to prepare, coagulate and cut tissue. 1) Instrumed Item No.: 250-08660; Surgimed - MLB Catalog Code: 91-112; Lot Numbers: 040110, 100112 Class II Additional caution statements have been added to the Instruction For Use for monopolar electrodes. The additional caution statements are as follows: 1) "To avoid tissue carbonation, the operation voltage of the HF generator must not exceed 650 peak voltage (Vp) for all monopolar electrodes." and 2) "For all monopolar electrodes, the useful life of this product is less than or equal to 50 cycles and less than or equal to 2 years." Instrumed International, Inc.
Devices The Symbia T Series consists of the T16, T6, T2, and T. The Symbia T integrates state-of-the-art SPECT and high quality spiral CT to provide precise attenuation correction and anatomical mapping. The system can also be used as a complete clinical SPECT system for general purpose, WB and SPECT applications. The Symbia T integrates state-of-the-art SPECT and high quality spiral CT to give the system SPECT functionality, with attenuation correction. The Symbia T2 integrates state-of-the-art SPECT and high quality dual slice spiral CT to give the system full functionality for all SPECT-only, SPECT-CT, or stand-alone CT diagnostic applications in Oncology, Neurology, and Cardiology. The Symbia T6 integrates state-of-the-art SPECT and high quality six slice spiral CT to give the system full functionality for all SPECT-only, SPECT-CT, or stand-alone CT diagnostic applications in Oncology, Neurology, and Cardiology. The Symbia T16 integrates state-of-the-art SPECT and high quality sixteen slice spiral CT to give the system full functionality for all SPECT-only, SPECT-CT, or stand-alone CT diagnostic applications in Oncology, Neurology, and Cardiology. For the Symbia T16/T6/T2, the ultra fast multi-slice spiral CT maximizes confidence in diagnostic stand-alone CT, as well as precise attenuation correction and anatomical mapping. Acquisitions can be performed with either the CT preceding the nuclear acquisition or vice versa. Indications for use: SPECT: To detect or image the distribution of radionuclides in the body or organ, using the following techniques: planar imaging, whole body imaging, tomographic imaging for isotopes with energies up to 588keV. CT: The CT component is intended to produce cross sectional images of the body by computer reconstruction of x-ray transmission data from either the same axial place taken at different angles or spiral planes taken at different angles. SPECT+CT: Perform CT scans and nuclear imaging studies within the same instrument. To obtain attenuation corrected images and to provide registration of anatomical and physiological images within the patient's anatomy. 1) Symbia T; Product Code: 10275007; Serial Numbers: 1055 , 1056 , 1057 , 1058 , 1060 , 1061 , 1062 , 1063 , 1064 , 1065 , 1066 , 1067 , 1068 , 1069 , 1070 , 1071 , 1072 , 1073 , 1074 , 1075 , 1076 ,  ...
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Class II Siemens Medical Solutions USA, Inc. is performing a field correction because we recently detected a rubber isolator with unfavorable aging properties. The function of the rubber isolator, which is situated within the rotate motor mounting assembly, may degrade over time and may impact motor support. The event does not pose a hazard by itself but could lead to a rupture of the drive belt which in turn could damage the gantry covers and make contact with the patient. Siemens Medical Solutions USA, Inc.
Devices The Symbia Intevo series consists of the Intevo 16, Intevo 6 and Intevo 2. This manual also describes the Symbia Intevo Excel. The Symbia Intevo series integrates state-of-the-art SPECT and high quality spiral CT to provide precise attenuation correction and anatomical mapping. The system can also be used as a complete clinical SPECT system for general purpose, whole body (WB) and SPECT applications. The Symbia Intevo Excel integrates state-of-the-art SPECT and high quality spiral CT to give the system SPECT functionality, with attenuation correction. The Symbia Intevo 2 integrates state-of-the-art SPECT and high quality dual slice spiral CT to give the system full functionality for all SPECT-only, xSPECT, or stand-alone CT diagnostic applications in Oncology, Neurology, and Cardiology. The Symbia Intevo 6 integrates state-of-the-art SPECT and high quality six slice spiral CT to give the system full functionality for all SPECT-only, xSPECT, or stand-alone CT diagnostic applications in Oncology, Neurology, and Cardiology. The Symbia Intevo 16 integrates state-of-the-art SPECT and high quality sixteen slice spiral CT to give the system full functionality for all SPECT-only, xSPECT, or stand-alone CT diagnostic applications in Oncology, Neurology, and Cardiology. Indications for use: SPECT: To detect or image the distribution of radionuclides in the body or organ, using the following techniques: planar imaging, whole body imaging, tomographic imaging for isotopes with energies up to 588keV. CT: The CT component is intended to produce cross sectional images of the body by computer reconstruction of x-ray transmission data from either the same axial place taken at different angles or spiral planes taken at different angles. SPECT+CT: Perform CT scans and nuclear imaging studies within the same instrument. To obtain attenuation corrected images and to provide registration of anatomical and physiological images within the patient's anatomy. 1) Symbia Intevo Excel; Product Code: 10764801; Serial Numbers: 1001 , 1002 , 1003 , 1004 , 1005 , 1006 , 1007 , 1009 , 1010 , 1011 , 1012 , 1013 , 1014 ; 2) Symbia Intevo 2; Product Code: 10764802; Serial Numbers: 1001 , 1002 , 1003 , 1004 , 1005 ; 3) Symbia Intevo 6; Product Code: 10764803; Serial Numbers: 1001 , 1002 , 1003 , 1004 , 1005 , 1006 , 1007 , 1008 , 1009 , 1010 , 1011 ; 4) Symbia Intevo 16; Product Code: 10764804; Serial Numbers: 1001 , 1002 , 1003 , 1004 , 1005 , 1006 , 1007 , 1008 , 1009 , 1010 , 1011 , 1012 , 1013 , 1014 , 1015 Class II Siemens Medical Solutions USA, Inc. is performing a field correction because we recently detected a rubber isolator with unfavorable aging properties. The function of the rubber isolator, which is situated within the rotate motor mounting assembly, may degrade over time and may impact motor support. The event does not pose a hazard by itself but could lead to a rupture of the drive belt which in turn could damage the gantry covers and make contact with the patient. Siemens Medical Solutions USA, Inc.
Food Goya Black Beans Frijoles Negros 15.5 oz (439g) Lots A2466 8 BB 06/21/18 and Lot A2466 8 BB 08/06/18 Class II Goya de Puerto Rico is recalling the following products due to a possible can seam defect that may compromise the integrity of the product. Tradewind Foods de Puerto Rico Inc.
Food Goya Whole Green Peas Chicharos 15.5 oz (439g) Lot A2461 8 BB 07/09/18 Class II Goya de Puerto Rico is recalling the following products due to a possible can seam defect that may compromise the integrity of the product. Tradewind Foods de Puerto Rico Inc.
Food Pink Beans sold under two brand names Goya and Jibarito (see labels description below) Goya Pink Beans Habichuelas Rosadas 15.5 oz. (439g) El Jibarito Habichuelas Rosadas 15.5 oz. (439g) Lots A2406 8 BB 07/12/18; A2406 8 BB 08/07/18; A2406 8 BB 08/09/18; A 2406 8 BB 08/14/18, A2406 8 BB 08/14/18(6 pack); A2406 8 BB 09/05/18; A2406 8 BB 09/16/18; A2406 8 BB 09/10/18; and A 2031 8 BB 08/14/18 (rosadas pink}-jibarito) Class II Goya de Puerto Rico is recalling the following products due to a possible can seam defect that may compromise the integrity of the product. Tradewind Foods de Puerto Rico Inc.
Food Goya Chick Peas Garbanzos 15.5 oz. (439g) Lot A2422 8 BB 07/11/18 Class II Goya de Puerto Rico is recalling the following products due to a possible can seam defect that may compromise the integrity of the product. Tradewind Foods de Puerto Rico Inc.
Food Goya Red Kidney Beans Habichuelas Coloradas 15.5 oz. (439 g) Lots: A2402 8 BB 08/08/18; A 2402 8 BB 09/05/18 and A2402 8 BB 04/02/19 Class II Goya de Puerto Rico is recalling the following products due to a possible can seam defect that may compromise the integrity of the product. Tradewind Foods de Puerto Rico Inc.
Food Goya Pinto Beans Habichuelas Pintas 15.5 oz. (439g) Lot A2437 8 BB 08/09/18 Class II Goya de Puerto Rico is recalling the following products due to a possible can seam defect that may compromise the integrity of the product. Tradewind Foods de Puerto Rico Inc.
Food Goya Pink Beans In sauce prepared with Olive Oil, Cilantro & Onion 15 oz. (425g) Lot A2055 8 BB 08/12/18 and A2055 8 BB 8/11/18 Class II Goya de Puerto Rico is recalling the following products due to a possible can seam defect that may compromise the integrity of the product. Tradewind Foods de Puerto Rico Inc.
Food Goya Black Bean Soup Prepared with Olive Oil, Bell Pepper & Onion 15 oz. (425g) Lot A 2067 8 BB 08/13/18 Class II Goya de Puerto Rico is recalling the following products due to a possible can seam defect that may compromise the integrity of the product. Tradewind Foods de Puerto Rico Inc.
Food Goya Pinto Beans In Sauce prepared with Olive Oil, Cilantro &Tomato 15 oz. (425g) Lot A2062 8 BB 08/15/18 Class II Goya de Puerto Rico is recalling the following products due to a possible can seam defect that may compromise the integrity of the product. Tradewind Foods de Puerto Rico Inc.
Food Goya Small Red Beans Habichuelas Coloradas Pequenas 15.5 OZ (439g) Lot A2420 BB 09/06/18 Class II Goya de Puerto Rico is recalling the following products due to a possible can seam defect that may compromise the integrity of the product. Tradewind Foods de Puerto Rico Inc.
Drugs CUBICIN (daptomycin for injection), 500 mg single-use vial, Rx only, Manufactured for: Cubist Pharmaceuticals, Inc., Lexington, MA 02421, NDC 67919-011-01, UPC 3 67919-011-01 6. Lot #: 081753F, 081803F, 081853F, Exp 08/2014; 090103F, 090153F, 090303F, 090353F, 090403F, 090453F, 090503F, Exp 09/2014; 100503F, 100553F, 100603F, 100653F, 100703F, 100753F, 100803F, 100853F, 100903F, Exp 10/2014; 101303F, 110303F, 110353F, 110403F, 110453F, 110503F, 110603F, 110653F, 110703F, Exp 11/2014; 120303F, 120353F, 120403F, 120453F, 120503F, 120553F, 120653F, 120703F, Exp 12/2014; 140453F, Exp  ...
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Class I Presence of Particulate Matter: Potential presence of glass particulate matter in the vials. Cubist Pharmaceuticals, Inc.
Veterinary ReBalance Antiprotozoal Oral Suspension (Sulfadiazine and Pyrimethamine For Oral Use in Horses Only Lot # 131110 Class II Low assay result for the Pyrimethamine at the 6-month stability time point. Pegasus Laboratories, Inc.
Drugs Dianeal Low Calcium (2.5 mEq/L) Peritoneal Dialysis Solution with 2.5% Dextrose, 5000 mL Ambu-Flex II container bags, Rx only, Baxter Healthcare Corporation, Deerfield, IL 60015; Product Code L5B5202, NDC 0941-0457-05. Lot #: C940700, C940841, Exp 05/16 Class I Presence of Particulate Matter: particulate matter was found during the manufacturing process. Baxter Healthcare Corp.
Biologics Platelets Pheresis Leukocytes Reduced Irradiated W043214051674; Class II Plateletpheresis product, lacking product quality control, was distributed. Blood Assurance Inc
Devices ENVOY 500 AST Reagent Kit, reference Model/Catalog 55255, for Envoy 500. Intended Use of the Product: Envoy 500 AST Reagent is for the quantitative in vitro diagnostic determination of aspartate aminotransferase (AST) in human serum and plasma using the Envoy 500 Chemistry System. Aspartate aminotransferase (AST) measurements are used in the diagnosis and treatment of certain types of liver and heart diseases. Lot 4014, Expiration date 07/2015; Lot 4051, Expiration date 09/2015; Lot 4074, Expiration date 11/2015; Class III Some users of ENVOY 500 AST Reagent Kit, reference 55255, for Envoy 500 systems are observing that Quality Control (QC) fails before the product expiry is reached. ELITech Clinical Systems SAS
Devices Percutaneous Trial Lead Kit Model 3046 (4 ch percutaneous lead). Used as part of the St. Jude Medical Neurostimulation system indicated for Spinal Chord Stimulation. Material 100077113, Batch 4558337 Class II The Directions for Use (DFU) manual contains information for devices that are not approved in the US. The correct US approved versions of the manuals were sent to the customers to replace the incorrect international manuals. St. Jude Medical, Inc.
Devices Percutaneous Trial Lead Kit Model 3086 (8 ch percutaneous lead). Used as part of the St. Jude Medical Neurostimulation system indicated for Spinal Chord Stimulation. Material 100077108, Batch 4519182 Class II The Directions for Use (DFU) manual contains information for devices that are not approved in the US. The correct US approved versions of the manuals were sent to the customers to replace the incorrect international manuals. St. Jude Medical, Inc.
Cosmetics Glow OLOGY Renew body butter packaged in 226 g (8 oz.) jars. Made in the USA. Distributed by DD Traders Inc. dba DEMDACO, Leawood, Kansas 66209. glowologyskincare.com Batch # 2025 (Lot 4112 and Lot 4113) Class II The product is contaminated with Pseudomonas luteola. Dd Traders Inc
Devices Persona The Personalized Knee System 2.5 mm Female Screw 48 mm Length Sterile Qty-2, Sterilized using irradiation, single use. Lot Numbers: 62155015 62165014 62165015 62165016 62165017 62165018 62182742 62182743 62188282 62188283 62191355 62191361 62191366 62191372 62210290 62210291 62227943 62230668 62230669 62230670 62230671 62230672 62230673 62230674 62230675 62230676 62255591 62255592 62255593 62255594 62255595 62255596 62255597 62255598 62283576 62283577 62283578 62288220 62288221 62288222 62288223 62288224 62305911 62305912 62305913 62305914 62327983 62327985 62327987 62327988 62327989 62348078 62348079 62348080 62348091 62348092 62348095 62379888 62379889 62379890 62379891 62391801 62391802 62391803 62391804 62391805 62391807 62391808 62408432 62408438 62408439 62408440 62408441 62417035 62417036 62417037 62444920 62444921 62444922 62444925 62453583 62453584 62453585 62475432 62475433 62475434 62475435 Class II The Persona 48mm X 2.5mm Female Screw is being recalled due to potential use of the screw in cortical bone, and corresponding stripping of the 2.5mm Persona Hex Driver. Zimmer, Inc.
Biologics Source Plasma OL0399363; Class II Source plasma product, for which donor eligibility was not complete, was distributed. DCI Biologicals Orlando LLC
Devices The Rejuvenator Chamber manufactured by Baro-Therapies, Inc. Product Usage: Indicated for relief from general aches and pains brought on by changes in the weather. All Lots, Series and Codes Class II The firm is distributing the Rejuvenator device without an approved 510(k). Baro-Therapies, Inc
Biologics Red Blood Cells Leukocytes Reduced W116113006606; Class II Blood products, collected from a donor considered to be at increased risk for variant Creutzfeldt- Jacob Disease (vCJD), were distributed. Avera McKennan Hospital & University Health Center
Biologics Plasma W116113006606; Class III Blood products, collected from a donor considered to be at increased risk for variant Creutzfeldt- Jacob Disease (vCJD), were distributed. Avera McKennan Hospital & University Health Center
Devices Siemens Dimension Vista® CHEM 1 CAL, lot 3GM081. The CHEM 1 CAL is an in vitro diagnostic product for the calibration of Calcium (CA), Cholesterol (CHOL), Creatinine (CREA), Glucose (GLU), Lactic Acid (LA), Magnesium (MG), Thyroxine (T4), Thyroxine Uptake (TU), Blood Urea Nitrogen (BUN), and Uric Acid (UA) methods on the Dimension Vista® System. lot 3GM081, exp. 07-01-2014 Class II Siemens Healthcare Diagnostics has received complaints for low recovery of Magnesium (MG) Quality Control (QC) and patient samples following calibration of MG with the Dimension Vista® CHEM 1 CAL, lot 3GM081. Investigation by Siemens confirms that QC and patient samples under-recovers MG by 0.25 mg/dL [0.10 mmol/L] across the assay range following calibration with 3GM081. Siemens Healthcare Diagnostics, Inc.
Devices eXpertDC intraoral x-ray, models: eXpert DC, NA, 75 Inch reach; eXpert DC, NA, 65 Inch reach; eXpert DC, CN, 55 Inch reach; eXpert DC, WW, 75 Inch reach; eXpert DC, WW, 65 Inch reach; eXpert DC, WW, 55 Inch reach; OEM Arm Assembly w/o cables; Assy, Articulated Arm & Tubehead, eDC; and Assy, Articulated Arm & Tubehead, 765DC Product Usage: intraoral x-ray Models: eXpert DC, NA, 75 Inch reach; eXpert DC, NA, 65 Inch reach; eXpert DC, CN, 55 Inch reach; eXpert DC, WW, 75 Inch reach; eXpert DC, WW, 65 Inch reach; eXpert DC, WW, 55 Inch reach; OEM Arm Assembly w/o cables; Assy, Articulated Arm & Tubehead, eDC; and Assy, Articulated  ...
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Class II Two (2) failures of the spring link components within the articulated arm assembly. The spring links broke during normal assembly process for the articulated arm during first cycle of the arm, prior to the 14lb tube head (full load) being installed onto the assembled articulated arm. Gendex Corp
Devices ADVIA Centaur Immunoassay System (including refurbished units), This system is intended for professional use in a laboratory environment only. Tests performed using this system are intended for in vitro diagnostic use. As with all diagnostic tests, a definitive clinical diagnosis should not be based on the results of a single test, but should only be made by the physician after all clinical and laboratory findings have been evaluated. All serial numbers. Model Numbers/Siemens Material Numbers (SMN) 10284980, 10286140, 10309524, 10309525, 10310210, 10313282, 10314322, 10316248, 10316372, 10316968, 10317060, 10317403, 10319111, 10319433, 10320929, 10321568, 10322149, 10322731, 10323204, 10325015, 10326217, 10327008, 10327379, 10328250, 10328647, 10329364, 10330873, 10331013, 10332617, 10334139, 10334759, 10337512, 10337526, 10339677, 10340551, 10340737, 10341051, 10341110, 10361010, 10361011, 10361012 Class II The firm has identified an issue with patient demographic information sent to the LIS from the ADVIA Centaur/ADVIA Centaur XP Immunoassay systems. Siemens has confirmed that under extremely rare circumstances patient demographic data from the previous order received from the LIS is merged with the next order. This issue can occur when the LIS data buffer on the ADVIA Centaur system becomes full and a particular character is found in the last five locations in the LIS data buffer. In this case, the incorrect patient demographic information will be transmitted to the LIS and will be displayed on the ADVIA Centaur user interface and instrument generated printed reports. Siemens Healthcare Diagnostics
Devices ADVIA Centaur XP Immunoassay System (including refurbished units), This system is intended for professional use in a laboratory environment only. Tests performed using this system are intended for in vitro diagnostic use. As with all diagnostic tests, a definitive clinical diagnosis should not be based on the results of a single test, but should only be made by the physician after all clinical and laboratory findings have been evaluated. All serial numbers. Model Numbers/Siemens Material Numbers (SMN) 10285219, 10316507, 10317207, 10317284, 10319668, 10320757, 10323213, 10324519, 10327135, 10327836, 10328940, 10329339, 10336292, 10338631, 10364455, 10388696, 10471899 Class II The firm has identified an issue with patient demographic information sent to the LIS from the ADVIA Centaur/ADVIA Centaur XP Immunoassay systems. Siemens has confirmed that under extremely rare circumstances patient demographic data from the previous order received from the LIS is merged with the next order. This issue can occur when the LIS data buffer on the ADVIA Centaur system becomes full and a particular character is found in the last five locations in the LIS data buffer. In this case, the incorrect patient demographic information will be transmitted to the LIS and will be displayed on the ADVIA Centaur user interface and instrument generated printed reports. Siemens Healthcare Diagnostics
Devices VITROS Chemistry Products PHYT (Phenytoin) Slides, REF/Product Code 829 8671, IVD. For in vitro diagnostic use only. VITROS Chemistry Products 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. Lot Number 2613-0150-4913, exp. 15-Nov-2014 Class II Ortho Clinical Diagnostics identified a potential for biased results to be generated when using VITROS PHYT Slides, Lot 2613-0150-4913. Some positively biased results were identified during testing of a different VITROS PHYT Slide lot; the affected slides were not released for distribution. Since Lot 2613-0150-4913 was manufactured in the same event, there is the potential for slides from this lot to also be affected. Ortho-Clinical Diagnostics
Devices SPECTRUM Pump, Model No. 35700BAX. Intended to be used for the controlled administration of intravenous fluids. Software Versions 5.02.06, 6.02.06, and 6.02.11; Affected Serial Numbers: 712090, 723687, 723842, 724966, 725820, 735977, 751130, 752124, 755174, 768538, 771990, 774743, 781406, 783736, 784698, 794466, 805797, 808901, 809113, 812462, 815932, 842120, 857926, 858672, 862085, 863721, 865630, 873459, 889597, 890260, 903748, 912619, 920574, 920589, 956346, 957394, 965402, 966684, 976931, 977550, 978361,  ...
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Class II One Service Technician may not have correctly serviced specific Sigma Spectrum Infusion Pumps according to established procedures during the time period of 5/5/2014 through 6/3/2014. Baxter Healthcare Corp.
Devices LAP-BAND AP SYSTEM AP Large with Access Port, Allergan, LAP-BAND AP SYSTEM Access Port I. Product was distributed for both the AP Large and AP Standard sizes. The LAP-BAND System is indicated for weight reduction for patients with obesity, with a Body Mass Index (BMI) of at least 40 kg/m2 or a BMI of at least 30 kg/m2 with one or more obesity related comorbid conditions. Lap-Band System AP Standard Catalog Number B-2240; Serial Numbers: 17760203, 17704664, 17704665, 17760205, 17760179, 17704672, 17704667, 17704659, 17760194, 17704653 Class II Product was distributed past its expiration date. Apollo Endosurgery Inc
Devices Array LaserLink, Manufactured by Lumenis, The Array" LaserLink" is a laser system accessory intended for use in the treatment of ocular pathology. " For the Posterior Segment, the Array" LaserLink" is indicated for use in Retinal Photocoagulation and Panretinal Photocoagulation of Vascular and Structural Abnormalities of the Retina and Choroid including: " Proliferative and Severe and Very Severe Non-Proliferative Diabetic Retinopathy " Macular Edema associated with Proliferative or Non-Proliferative Diabetic Retinopathy " Choroidal Neovascularization " Retinal Neovascularization associated with Retinal Occlusive Disease (Branch Retinal Vein Occlusion; Central Retinal Vein Occlusion) " Macular Edema associated with Branch Retinal Vein Occlusion " Retinal Tears and Detachments And Anterior Segments as follows: " Iridotomy in Closed Angle Glaucoma " Trabeculoplasty in Open Angle Glaucoma All assembled units since product release, Part Number: GA-0006700. Class II Lumenis initiated a field-correction for the Array Laser Link", GA-0006700 (SN XXYYZZ) because the system may project an erroneous pattern display on the retina, which is different than the desired pattern. Lumenis, Inc.
Food Basil Pesto Pasta packaged in a non-flex plastic tub, net wt 8 oz. A green sticker is placed on the lid of the package which contains the lot code. Product is refrigerated 0825, 0826, 0827, and 0828. Code represents month (08) and day (25) of expiration Class I Tj's Place is recalling Basil Pesto Pasta packed in 8 oz. plastic tubs because it has the potential to be contaminated with Listeria monocytogenes. TJs Place
Veterinary Ivermax (Ivermectin) 1% sterile solution is provided in a 500 mL plastic bottle suitable for use with automatic syringe equipment. Each bottle contains sufficient solution to treat 100 head of 550 lb (250 kg) cattle or 1000 head of 38 lb (17.3 kg) swine. Item Number: 1IVE038, Lot Number: 2E055 Class II This recall has been initiated due to incorrect information printed on the bottle carton. Specifically the carton indicates that the manufacturing date was May 2014 where as the correct information (as indicated on the bottle) is that the expiry date is May 2014. There is a chance that customers may use the product after the expiration date based on the carton label. The bottle inside the carton is correctly labeled as "EXP MAY 2014". Bimeda MTC Animal Health Inc.
Devices Philips Expression MR200 MRI Patient Monitoring System Model 866120 Model 866120 with the following lots #'s: US33600006, US33600007, US33600011, US33600012 and US33600013 Class II During production, excess metal (aluminum) debris was found stuck to the cling plastic that covers the device's pole assembly. The metallic debris could affect system performance due to the potential for a failure to power up or loss of power. This could result in the loss of monitoring and a delay in diagnosis of the patient. Invivo Corporation
Devices Hudson RCI® Pediatric Anesthesia Breathing Circuits, Single Patient Use, Rx Only, Product Usage: To administer medical gases to a patient during anesthesia. It provides both an inhalation and exhalation route and may include a connector, adaptor, and Ypiece. Product Code: 313905, Lot #02F1300085; Product Code: 353900,  ...
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Class I The pediatric breathing circuits can crack prior to and during use. Teleflex Medical
Devices ASSEMBLY, PATIENT SIDE CART, PS4000 used with the da Vinci Xi Surgical System. Product Usage: The Intuitive Surgical Endoscope Instrument Control System (da Vinci Surgical System, Model IS4000) is intended to assist in the accurate control of Intuitive Surgical Endoscopic Instruments including rigid endoscopes, blunt and sharp endoscopic dissectors, scissors, scalpels, forceps/pick-ups, needle holders, endoscopic retractors, electrocautery and accessories for endoscopic manipulation of tissue, including grasping, cutting, blunt and sharp dissection, approximations, ligation, electrocautery, suturing and delivery and placement of microware and cryogenic ablation probes and accessories, during urologic surgical procedures, general laparoscopic surgical procedures, gynecologic laparoscopic surgical procedures, general thoracoscopic surgical procedures and thoracoscopically-assisted cardiotomy procedures. The system can also be employed with adjunctive mediastinotomy to perform coronary anastomosis during cardiac revascularization. The system is indicated for adult and pediatric use. It is intended to be used by trained physicians in an operating room environment in accordance with the representative, specific procedures set forth in the Professional Instructions for Use. PATIENT SIDE CART, PS4000. Part Number: 380652 Serial Numbers: 353668 351929 354943 351749 354389 351849 355824 363594 361993 360419 358104 357083 351852 351845 361323 358107 364412 364505 361994 364001 349166 364112 358774 359361 357082 363784 353632 364343 358109 358848 351052 354234 354552 356258 363752 354233 358775 364200 359222 364619 363868 354714 361989 361391 361094 351853 353410 355206 357698 358480 365395 359223 355996 363681 360417 355623 365465 365839 356530 364620 365928 365862 356532 366904 366884 367674 368046 367426 356683 360413 356533 368071 368681 358930 357081. Class II Correction due to the detection of a motor sensor failure in the Patient Cart instrument arms of the da Vinci Xi (IS4000) Surgical Systems after a mid-procedure restart. Intuitive Surgical, Inc.
Devices The Ingenuity CT, Ingenuity Core, and Ingenuity Core128 scanners are Computed Tomography X-ray systems intended to produce cross-sectional images of the body by computer reconstruction of X-ray transmission data taken at different angles and planes. This device may include signal analysis and display equipment, patient and equipment supports, components and accessories Ingenuity CT: 728326 300005,300010,300012,300016,300017,300019,300020,300021,300028,300029, 300031,300032,300033,300035,300037,300039,300043,300047,300050,300051, 300052,300054,300055,300057,300060,300061,300062,300063,300072,300074, 300082,300086,300087,300089,300094,300095,300100,300101,300102,300106, 300108,300110,300112,300113,300129,300135,300136,300140,300143 Ingenuity Core: 728321 310001,310002,310009,310055,310059,310064,310069,310070,310087,333015 Ingenuity Core128: 728323 300137,320003,320005,320006,320018,320024,320029,320030,320033,320037, 320078,320092,320099,320103,320114,336011,336012,336013,336016,336018 Class II Ingenuity CT system can mislabel the exposure that results in an image in the incorrect order that it was taken by the user. Philips Medical Systems (Cleveland) Inc
Drugs Diclofenac Sodium and Misoprostol Delayed-Release Tablets, 75 mg/0.2 mg, 60-count bottle, Rx only, Manufactured by: Watson Laboratories, Inc., Corona, CA 92880, NDC 0591-0398-60, UPC 3 05910 39860 6. Lot #: 605956A, 605958A, Exp. 9/30/2014; 644678M, Exp. 10/31/2014; 661841A, Exp. 11/30/2014; 717469A, Exp 2/28/2015 Class II Failed Tablet/Capsule Specifications: Recall due to complaints of split or broken tablets. Actavis Laboratories, FL, Inc.
Drugs Diclofenac Sodium and Misoprostol Delayed-Release Tablets, 50 mg/0.2 mg, 60-count bottle, Rx only, Manufactured by: Watson Laboratories, Inc., Corona, CA 92880, NDC 0591-0397-60, UPC 3 05910 39760 9. Lot #: 660513A, Exp. 10/31/2014 Class II Failed Tablet/Capsule Specifications: Recall due to complaints of split or broken tablets. Actavis Laboratories, FL, Inc.
Devices Siemens Ysio Max system The Ysio Max is a radiographic system used in hospitals, clinics, and medical practices. Ysio Max enables radiographic and tomographic exposures of the whole body including: skull, chest, abdomen, and extremities and may be used on pediatric, adult and bariatric patients. It can also be used for intravenous, small interventions (like biopsy, punctures, etc.) and emergency (trauma, critical ill) applications. Exposures may be taken with the patient sitting, standing, or in the prone position. The Ysio Max system is not meant for mammography. The Ysio Max uses integrated or portable digital detectors for generating diagnostic images by converting x-rays into electronic signals. Ysio Max is also designed to be used with conventional film/screen or Computed Radiography (CR) cassettes. Siemens Ysio Max material #s: 10762470, serial numbers: 24033 24028 24024 24034 24015 24026 24014 24016 24025 24037 Class II Two malfunctions posing potential risk to patients were identified with Siemens Ysio Max, AXIOM Luminos dRF Max, Uroskop Omnia Max, and Luminos Agile Max systems with a specific set of serial numbers that will cause lost images due to an automatic Radiology Information System (RIS) worklist update, thus causing examinations to be repeated. Image label may also be displayed incorrectly after images have been sent to PACS or hardcopy/filming, thus leading to potentially incorrect diagnosis. Siemens Medical Solutions USA, Inc
Devices Siemens AXIOM Luminos dRF Max systems The Axiom Luminos dRF is intended to be used as a universal diagnostic imaging system for radiographic and fluoroscopic studies. Using a digital flat detector, it can perform a range of applications including general R/F, angiography and pediatric examinations. The Axiom Luminos dRF is a device intended to visualize anatomical structures by converting a pattern of X-ray into a visible image. Siemens AXIOM Luminos dRF Max system material #s: 10762471 with serial number: 5037. Class II Two malfunctions posing potential risk to patients were identified with Siemens Ysio Max, AXIOM Luminos dRF Max, Uroskop Omnia Max, and Luminos Agile Max systems with a specific set of serial numbers that will cause lost images due to an automatic Radiology Information System (RIS) worklist update, thus causing examinations to be repeated. Image label may also be displayed incorrectly after images have been sent to PACS or hardcopy/filming, thus leading to potentially incorrect diagnosis. Siemens Medical Solutions USA, Inc
Devices Siemens Uroskop Omnia Max system The Uroskop Omnia is a solid state detector fluoroscopic X-Ray system, primarily for urological applications (functional x-ray diagnostic, endourology and minimal invasive urology/surgery). The system,, which includes a radiologic/urologic treatment table, may be used for urological, gastroenterological and gynecological treatment, planning and diagnostic procedures including but not limited to: "Querying and retrieving patient history information and/or previous diagnosis and images from other modalities; "X-ray examinations of the urogenital area "Ultrasound examinations "Endourological interventions "Percutaneous interventions "Laparoscopy "Application of fistula "Simple procedures "Extracorporeal shock wave lithotripsy "Uroflow/urodynamics "Pediatric radiological and therapeutic applications Siemens Uroskop Omnia Max system, material #s: 10762473, serial numbers: 4014 4015 Class II Two malfunctions posing potential risk to patients were identified with Siemens Ysio Max, AXIOM Luminos dRF Max, Uroskop Omnia Max, and Luminos Agile Max systems with a specific set of serial numbers that will cause lost images due to an automatic Radiology Information System (RIS) worklist update, thus causing examinations to be repeated. Image label may also be displayed incorrectly after images have been sent to PACS or hardcopy/filming, thus leading to potentially incorrect diagnosis. Siemens Medical Solutions USA, Inc
Devices Siemens Luminos Agile Max system The Luminos Agile is intended to be used as a universal imaging system for radiographic and fluoroscopic studies. Using either film cassettes or a digital mobile flat detector, it can perform a range of applications including general R/F, angiography and pediatric examinations. Luminos Agile is applicable to emergency treatment on an outpatient basis, as well as for bedside examinations. Siemens Luminos Agile Max system material #s: 10762472, with serial numbers: 61013 61015 61011 61014 61017 Class II Two malfunctions posing potential risk to patients were identified with Siemens Ysio Max, AXIOM Luminos dRF Max, Uroskop Omnia Max, and Luminos Agile Max systems with a specific set of serial numbers that will cause lost images due to an automatic Radiology Information System (RIS) worklist update, thus causing examinations to be repeated. Image label may also be displayed incorrectly after images have been sent to PACS or hardcopy/filming, thus leading to potentially incorrect diagnosis. Siemens Medical Solutions USA, Inc
Food 2/24 ounce clear plastic bags of 3/8 inch diced Roma tomatoes. These bags are in a cardboard carton. The bags and carton have a yellow label that reads in part: Boskovich Farms, Inc Costco Deli Dept. 63 ***QUINOA SALAD KIT Item # 624843 CONTENTS: (2) QUINIA MIX *** (2) Diced Roma *** NET WT: 23.96 LBS. L091-EI03718, L091-EI08269, L-091-EI05092, L091-10510510. Class I Boskovich Farms is recalling Roma Tomatoes because they may be contaminated with Salmonella. Boskovich Farms, Inc
Food 2-5 lb. clear plastic overwrapped black poly trays of 3/8" diced Roma Tomato per cardboard carton. Cardboard carton labeled: 2-5 LB. DICED TOMATOES 3/8  PACKED BY BOSKOVICH FARMS OXNARD CA, 93030 PRODUCT OF MEXICO. L091-EI03712, L091-EI09362. Class I Boskovich Farms is recalling Roma Tomatoes because they may be contaminated with Salmonella. Boskovich Farms, Inc
Drugs CREON (pancrelipase) Delayed-Release Capsules, Lipase 24,000 USP Units, 250 Capsule Bottles, Rx Only. Marketed by: AbbVie Inc., North Chicago, IL 60064, Product of Germany. NDC 0032-1224-07. Lot #: 1020156; Expiry: 3/31/2016 Class II Presence of Foreign Tablets/Capsules; Presence of co-mingled LipaCreon 13000. AbbVie Inc
Drugs DOPamine Hydrochloride and 5% Dextrose INJ, USP, 200 mg per 250 mL, Rx Only, Baxter USA, NDC 0338-1005-02. Lot# P303172; Exp. 12/14 Class II Lack of Assurance of Sterility: A small cut in the solution bag may have been introduced during the manufacturing process, resulting in a leak of the bag into the overpouch. Baxter Healthcare Corp.
Devices GE Healthcare Precision 500D, Classical R&F System. Product Usage: The Precision 500D R&F X-ray System is intended to be used as a universal diagnostic imaging system for radiographic and fluoroscopic examinations, including general R&F and Pediatric examinations. Mfg Lot or Serial # System ID 00000015997MO7 260347RF 00000149474MO9 423778ENRF1 00000149476MO4 216343R1 00000149477MO2 423778ERF1 00000149478MO0 407296PRE 00000149479MO8 765482WR2 00000149480MO6 478633PDI3 00000149481MO4 404321P500D 00000149482MO2 435865500D 00000149483MO0 210297NCRF1 00000149484MO8 334705EA3 00000149485MO5 314577GC64 00000149486MO3 423224RF1 00000149487MO1 847432HP8 00000149488MO9 423778ERF2 00000149489MO7 210616MCTRF 00000149490MO5 773633EP500 00000149491MO3 763520N8 00000149492MO1 773CMHCSRF 00000149493MO9 904202RF 00000149495MO4 208557RM1 00000149496MO2  ...
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Class II GE Healthcare has become aware of a potential safety issue involving missing screws used for mounting the overhead Video Monitor to the tray assembly on a single monitor suspension. This issue affects the Precision 500D X-ray imaging systems. GE Healthcare, LLC
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