Estados Unidos Recalls
Retiros de seguridad del consumidor de la FDA, CPSC, NHTSA y USDA FSIS.
FDA DevicesSyva EMIT 2000 Quinidine Assay REF: 4Q019UL Contents: 1x28 mL, 1x14mL
Syva EMIT 2000 Quinidine Assay REF: 4Q019UL Contents: 1x28 mL, 1x14mL
Due to unacceptable precision performance exhibited in certain lots of the Emit 2000 Quinidine Assay, which may lead to erroneously elevated quinidine measurements, creating risk of sub-optimal patient treatment, including potential life-threatening cardiac arrhythmias or inadequate antimalarial therapy.
FDA DevicesBeckman Coulter DxC 500i Clinical Analyzer Modules using software version 1.5 or lower: 1) DxC 500 AU Module w/ISE, DxC 500i, Part Number C63522; 2) DxC 500 AU Module, DxC 500i, Part Number C63521; 3) Access 2 Module, DxC 500i, Part Number C13252; DxC 500 AU Clinical Chemistry Analyzers
Beckman Coulter DxC 500i Clinical Analyzer Modules using software version 1.5 or lower: 1) DxC 500 AU Module w/ISE, DxC 500i, Part Number C63522; 2) DxC 500 AU Module, DxC 500i, Part Number C63521; 3) Access 2 Module, DxC 500i, Part Number C13252; DxC 500 AU Clinical Chemistry Analyzers
a software defect in which the Parameter Package (PP) import logic overwrites all predefined calculated test rules, including those previously modified by the user, upon import of a new Parameter Package version. As a result, usercustomized calculated test rules revert silently to their default expressions, potentially generating erroneous patient test results without an explicit error notification. The issue affects instruments running software version 1.5 or lower and only occurs when a new Parameter Package is imported to a system that already has an existing Parameter Package onboard; new installations are not affected.
FDA DevicesAmerican Contract Systems medical procedure kits and trays labeled as: 1) ANTERIOR CERVICAL PACK - 205988, Model Item Number MHAC65AH; 2) SPINE PACK - 206013, Model Item Number MHSP99AF.
American Contract Systems medical procedure kits and trays labeled as: 1) ANTERIOR CERVICAL PACK - 205988, Model Item Number MHAC65AH; 2) SPINE PACK - 206013, Model Item Number MHSP99AF.
The recall notice was initiated due to a Medicom Urgent Medical Device Recall. Medicom is recalling specific lots of Ritmed¿ Neurological Sponges Non-Sterile Models 55992C to 55998C due to potential for unexpected variability of endotoxin levels on the products.
FDA DevicesBeckman Coulter, Emit 2000 Quinidine Assay REF: OSR4Q229 Contents: R1: 2 x 23 mL;R2 2x13 mL
Beckman Coulter, Emit 2000 Quinidine Assay REF: OSR4Q229 Contents: R1: 2 x 23 mL;R2 2x13 mL
Due to unacceptable precision performance exhibited in certain lots of the Emit 2000 Quinidine Assay, which may lead to erroneously elevated quinidine measurements, creating risk of sub-optimal patient treatment, including potential life-threatening cardiac arrhythmias or inadequate antimalarial therapy.
FDA DrugsTralement (trace elements injection 4*, USP), packaged in a) 1mL Single Dose vials (NDC 0517-9305-01) and b) 5x1mL Single Dose vials (NDC 0517-9305-25), Rx only, AMERICAN REGENT, INC., SHIRLEY, NY 11967.
Tralement (trace elements injection 4*, USP), packaged in a) 1mL Single Dose vials (NDC 0517-9305-01) and b) 5x1mL Single Dose vials (NDC 0517-9305-25), Rx only, AMERICAN REGENT, INC., SHIRLEY, NY 11967.
Presence of Particulate Matter: Product contaminated with particulate matter identified as hair, glass and/or paraformaldehyde
FDA DevicesBlanketrol II Model 222S; Thermal regulating system.
Blanketrol II Model 222S; Thermal regulating system.
Overheating of the 115V CPU board may cause the device to shut down.
FDA DrugsCyanocobalamin injection USP, 1,000 mcg/mL, For IM or SC Use Only, packaged in a) 1 mL Multi-Dose Vial (NDC 0517-0031-01), and b) 25x1 mL Multi-Dose Vials (NDC 0517-0031-25) Rx only, AMERICAN REGENT, INC., SHIRLEY, NY 11967.
Cyanocobalamin injection USP, 1,000 mcg/mL, For IM or SC Use Only, packaged in a) 1 mL Multi-Dose Vial (NDC 0517-0031-01), and b) 25x1 mL Multi-Dose Vials (NDC 0517-0031-25) Rx only, AMERICAN REGENT, INC., SHIRLEY, NY 11967.
Presence of Particulate Matter: Product contaminated with particulate matter identified as hair, glass and/or paraformaldehyde
FDA DevicesOne-Piece Guedel Airway, size 00, ISO 5.0, Blue. Oropharyngeal Airway Device.
One-Piece Guedel Airway, size 00, ISO 5.0, Blue. Oropharyngeal Airway Device.
Devices could potentially be occluded or partially occluded.
FDA DevicesOverStitch Suture Cinch, 1pk. Endoscopic tissue approximation device.
OverStitch Suture Cinch, 1pk. Endoscopic tissue approximation device.
Device may fail to deploy the cinch implant and/or fail to cut the suture as intended.
FDA DevicesHalyard LAVH PACK, Model/Catalog Number: USAR053-11 containing Clearify Visualization System (5303907).
Halyard LAVH PACK, Model/Catalog Number: USAR053-11 containing Clearify Visualization System (5303907).
The kit component was subjected to EO sterilization, contrary to the manufacturer recommendation, which may have led to the component leaking in a kit.
FDA DevicesTD Navio Maxi Speech Generating Device Model/Catalog Number: 1000799
TD Navio Maxi Speech Generating Device Model/Catalog Number: 1000799
Under certain conditions, the battery mounting tabs may become damaged, allowing the battery to move within the device enclosure, potentially leading to an internal short circuit. This may cause localized heating and gas venting within the device enclosure.
FDA DrugsMorphine Sulfate Injection, USP, 2 mg /mL, 1 mL single-dose Simplist prefilled syringes, For Intramuscular or Intravenous use, Rx only, Fresenius Kabi, Lake Zurich, IL. Unit of Use NDC Number 76045-004-01; Unit of Sale NDC Number 76045-004-11
Morphine Sulfate Injection, USP, 2 mg /mL, 1 mL single-dose Simplist prefilled syringes, For Intramuscular or Intravenous use, Rx only, Fresenius Kabi, Lake Zurich, IL. Unit of Use NDC Number 76045-004-01; Unit of Sale NDC Number 76045-004-11
Labeling: Label Mixup: MicroVault labeled as Morphine 2 mg/1 mL, contains a Prefilled Syringe of Dilaudid 0.5 mg/0.5 mL.
FDA FoodWhole Foods Mango Pineapple Salsa sold as a condiment in Caribbean Mango Pineapple Turkey Burger. Keep Refrigerated. Packed in various sized clear plastic containers. Product is weighed and a finished product label is applied. Products contain the following PLU Cods located under label bar code: 25867600000, 21195900000, 46000040275, 27578600000. Packed for Whole Foods Market, 4301 W. William Cannon, Austin, TX 78749.
Whole Foods Mango Pineapple Salsa sold as a condiment in Caribbean Mango Pineapple Turkey Burger. Keep Refrigerated. Packed in various sized clear plastic containers. Product is weighed and a finished product label is applied. Products contain the following PLU Cods located under label bar code: 25867600000, 21195900000, 46000040275, 27578600000. Packed for Whole Foods Market, 4301 W. William Cannon, Austin, TX 78749.
Salsa and Guacamole products were made with jalapenos that may be contaminated with Salmonella.
FDA DrugsCarbamazepine Tablets, USP, 200mg, 1000 count bottles, Rx only, Manufactured by: Taro Pharmaceutical Industries Ltd., Haifa Bay, Israel 2624761, Distributed by: Taro Pharmaceuticals USA, Inc., Hawthorne, NY 10532, NDC 51672-4005-3.
Carbamazepine Tablets, USP, 200mg, 1000 count bottles, Rx only, Manufactured by: Taro Pharmaceutical Industries Ltd., Haifa Bay, Israel 2624761, Distributed by: Taro Pharmaceuticals USA, Inc., Hawthorne, NY 10532, NDC 51672-4005-3.
CGMP Deviations; black spots found on tablets from burnt excipient during manufacturing
FDA DevicesFort Defiance Industries (FDI), Automated Field Steam Sterilizer REF: P2131
Fort Defiance Industries (FDI), Automated Field Steam Sterilizer REF: P2131
The Automated Field Steam Sterilizer's water recovery system 120V Amphenol connector may experience an intermittent loss of ground continuity, which could result in an unreliable fault current return path.
FDA FoodGet Fresh Produce Jalapeno Peppers. Item 01896 - 2 lb. box; Item 01894 - 10 lb. box
Get Fresh Produce Jalapeno Peppers. Item 01896 - 2 lb. box; Item 01894 - 10 lb. box
Potential Salmonella contamination
FDA FoodDairyland Produce, LLC Pepper Jalapeno, repackaged into the following sized clear plastic bags: 1. 1 lb., item number 01213, UPC 0009907729 2. 3 lbs., item number 02611, UPC 0009902703; 3. 5 lbs., item number 72618, UPC 0009900168; and 4. 10 lbs., item number 71537, UPC 0009900167. Only the 5 lb. packaging is available to consumers and retail stores.
Dairyland Produce, LLC Pepper Jalapeno, repackaged into the following sized clear plastic bags: 1. 1 lb., item number 01213, UPC 0009907729 2. 3 lbs., item number 02611, UPC 0009902703; 3. 5 lbs., item number 72618, UPC 0009900168; and 4. 10 lbs., item number 71537, UPC 0009900167. Only the 5 lb. packaging is available to consumers and retail stores.
Jalapenos may be contaminated with Salmonella.
FDA DrugsAMINAOCAPROIC ACID INJECTION, USP, 250 mg/mL (5 g/20 mL), packaged in a) 20 mL MULTIPLE DOSE VIAL FOR IV INFUSION (NDC 0517-9120-01), and b) 25x20 mL MULTIPLE DOSE VIALS (NDC 0517-9120-25), Rx Only, American Regent, Inc., Shirley, NY 11967.
AMINAOCAPROIC ACID INJECTION, USP, 250 mg/mL (5 g/20 mL), packaged in a) 20 mL MULTIPLE DOSE VIAL FOR IV INFUSION (NDC 0517-9120-01), and b) 25x20 mL MULTIPLE DOSE VIALS (NDC 0517-9120-25), Rx Only, American Regent, Inc., Shirley, NY 11967.
Presence of Particulate Matter: Product contaminated with particulate matter identified as hair, glass and/or paraformaldehyde
FDA FoodJalapeno Pepper packaged in bulk generic Coast Tropical cardboard packaging. Packaged in assorted bulk package sizes (10lbs, 40lbs, 35lbs, 20lbs, 38lbs 1 1/9 Bushel) ; Product of MX; Coast Tropical TX UPCs 73296608113; 73296600558; 73296610927; 73296600559; 732966107055; 02060042710
Jalapeno Pepper packaged in bulk generic Coast Tropical cardboard packaging. Packaged in assorted bulk package sizes (10lbs, 40lbs, 35lbs, 20lbs, 38lbs 1 1/9 Bushel) ; Product of MX; Coast Tropical TX UPCs 73296608113; 73296600558; 73296610927; 73296600559; 732966107055; 02060042710
Potential Salmonella Javiana contamination
FDA DrugsSelenious Acid Injection, USP 12 mcg/2 mL (6 mcg/2mL), For intravenous use, packaged in a) 2mL Single-Dose Vial (NDC 0517-6502-01), and b)10x2mL Single-Dose Vial (NDC 0517-6502-10), Rx Only, AMERICAN REGENT, INC., SHIRLEY, NY 11967.
Selenious Acid Injection, USP 12 mcg/2 mL (6 mcg/2mL), For intravenous use, packaged in a) 2mL Single-Dose Vial (NDC 0517-6502-01), and b)10x2mL Single-Dose Vial (NDC 0517-6502-10), Rx Only, AMERICAN REGENT, INC., SHIRLEY, NY 11967.
Presence of Particulate Matter: Product contaminated with particulate matter identified as hair, glass and/or paraformaldehyde
FDA FoodWhole Foods Salsa, Heirloom Tomato. Keep Refrigerated. Packed in various sized clear plastic containers. Product is weighed and a finished product label is applied. Products contain the following PLU Cods located under label bar code: 22860200000, 24091700000, 24118800000, 25024800000, 29648100000, 29648700000, 46000049560. Packed for Whole Foods Market, located at either 1745 W. Market Street, Akron, OH 44313 or 4301 W. William Cannon, Austin, TX 78749.
Whole Foods Salsa, Heirloom Tomato. Keep Refrigerated. Packed in various sized clear plastic containers. Product is weighed and a finished product label is applied. Products contain the following PLU Cods located under label bar code: 22860200000, 24091700000, 24118800000, 25024800000, 29648100000, 29648700000, 46000049560. Packed for Whole Foods Market, located at either 1745 W. Market Street, Akron, OH 44313 or 4301 W. William Cannon, Austin, TX 78749.
Salsa and Guacamole products were made with jalapenos that may be contaminated with Salmonella.
FDA DrugsPEMRYDI RTU(pemetrexed injection), 500 mg/50 mL (10 mg/mL), Single-dose vial, Rx only, Manufactured by: Zydus Lifesciences Limited, Ahmedabad, India; Distributed by: Amneal Pharmaceuticals LC, Bridgewater, NY 08807. NDC: 70121-2461-1
PEMRYDI RTU(pemetrexed injection), 500 mg/50 mL (10 mg/mL), Single-dose vial, Rx only, Manufactured by: Zydus Lifesciences Limited, Ahmedabad, India; Distributed by: Amneal Pharmaceuticals LC, Bridgewater, NY 08807. NDC: 70121-2461-1
Discolored solution. The firm has received market complaints reporting green to dark green discoloration in certain vials
FDA DrugsniCARdipine Hydrochloride Injection, USP, 25 mg/10mL (2.5 mg/mL), packaged in a) 10 mL Single Dose Vial (NDC 72572-470-01) and b) 10x10 mL Single Dose Vials (NDC 72572-470-10), Rx Only, Mfd for: Civica, Inc., Lehi, UT, Mfd by: American Regent, Inc., New Albany, OH 43054.
niCARdipine Hydrochloride Injection, USP, 25 mg/10mL (2.5 mg/mL), packaged in a) 10 mL Single Dose Vial (NDC 72572-470-01) and b) 10x10 mL Single Dose Vials (NDC 72572-470-10), Rx Only, Mfd for: Civica, Inc., Lehi, UT, Mfd by: American Regent, Inc., New Albany, OH 43054.
Presence of Particulate Matter: Product contaminated with particulate matter identified as hair, glass and/or paraformaldehyde
FDA DevicesOne-Piece Guedel Airway, size 000, ISO 3.5, Light Green. Oropharyngeal Airway Device.
One-Piece Guedel Airway, size 000, ISO 3.5, Light Green. Oropharyngeal Airway Device.
Devices could potentially be occluded or partially occluded.