Estados Unidos Recalls
Retiros de seguridad del consumidor de la FDA, CPSC, NHTSA y USDA FSIS.
FDA FoodLoard's Sea Salt Caramel Ice Cream - 32 oz
Loard's Sea Salt Caramel Ice Cream - 32 oz
Undeclared Milk, Soy, Sulfites.
FDA FoodLoard's Lime Sherbert - 32 oz
Loard's Lime Sherbert - 32 oz
Undeclared Milk, Wheat, Soy, Yellow #5, Green #3.
FDA FoodLoard's Pumpkin Ice Cream - 32 oz
Loard's Pumpkin Ice Cream - 32 oz
Undeclared Milk, Yellow #6.
FDA FoodMILK WASH NET WEIGHT: 50OZ (1417g) Packed Exclusively For: Chick-fil-A, Inc. 5200 Buffington Road Atlanta, GA 30349
MILK WASH NET WEIGHT: 50OZ (1417g) Packed Exclusively For: Chick-fil-A, Inc. 5200 Buffington Road Atlanta, GA 30349
Potential Salmonella contamination. The firm was notified from their supplier that the nonfat dry milk may be contaminated with Salmonella.
FDA DevicesOne Step K in vitro diagnostic test REF: 81A4
One Step K in vitro diagnostic test REF: 81A4
The devices were distributed without required FDA premarket clearance or approval.
FDA DevicesMedline Convenience Kits: 1) WMC I D PACK-LF, Model Number: DYNJ50806L
Medline Convenience Kits: 1) WMC I D PACK-LF, Model Number: DYNJ50806L
Medline has identified issues related to calibration of the equipment used to sterilize and package the devices. All products were exposed to the validated sterilization and packaging cycles; however, the identified calibration issues have the potential to impact the sterility assurance level (SAL) of the Recalled Products.
FDA FoodLoard's Rainbow Sherbert - 32 oz
Loard's Rainbow Sherbert - 32 oz
Undeclared Milk, Soy, Yellow #5, Red #40, Green #3.
FDA FoodLoard's Caramel Cashew Ice Cream - 32 oz
Loard's Caramel Cashew Ice Cream - 32 oz
Undeclared Milk, Cashews, Soy, Sulfites.
FDA DevicesMedline Convenience Kits: 1) BAPTIST FLOYD ENDO GI KIT, Model Number: DYKE1455B; 2) GI LAB OTHER ENDO KIT, Model Number: DYKE1721
Medline Convenience Kits: 1) BAPTIST FLOYD ENDO GI KIT, Model Number: DYKE1455B; 2) GI LAB OTHER ENDO KIT, Model Number: DYKE1721
Medline has identified issues related to calibration of the equipment used to sterilize and package the devices. All products were exposed to the validated sterilization and packaging cycles; however, the identified calibration issues have the potential to impact the sterility assurance level (SAL) of the Recalled Products.
FDA FoodLoard's Vanilla Ice Cream - 32 oz; 56 oz
Loard's Vanilla Ice Cream - 32 oz; 56 oz
Undeclared Milk.
FDA DrugsDuloxetine Delayed-Release Capsules USP, 60mg, Rx Only, 90-count bottle, Mfr. by Towa Pharmaceutical Eurpoe S.L., Martorelles, (Barcelona), Spain, Dist. by. Breckenridge Pharmaceutical, Inc., Berkely Heights, NJ 07922, NDC 51991-748-90.
Duloxetine Delayed-Release Capsules USP, 60mg, Rx Only, 90-count bottle, Mfr. by Towa Pharmaceutical Eurpoe S.L., Martorelles, (Barcelona), Spain, Dist. by. Breckenridge Pharmaceutical, Inc., Berkely Heights, NJ 07922, NDC 51991-748-90.
CGMP Deviations; presence of N-nitroso-duloxetine impurity above the FDA recommended limit
FDA FoodLoard's Champagne Sherbert - 32 oz
Loard's Champagne Sherbert - 32 oz
Undeclared Milk, Red #40.
FDA DevicesMedline Convenience Kits: 1) PPE KIT, Model Number: DYK1011945P
Medline Convenience Kits: 1) PPE KIT, Model Number: DYK1011945P
Medline has identified issues related to calibration of the equipment used to sterilize and package the devices. All products were exposed to the validated sterilization and packaging cycles; however, the identified calibration issues have the potential to impact the sterility assurance level (SAL) of the Recalled Products.
FDA FoodGarland Fresh Peeled Garlic 6 oz. bag
Garland Fresh Peeled Garlic 6 oz. bag
The potential contamination with Clostridium botulinum, due to risk of temperature abuse during chilled storage at the firm
FDA DevicesMedline Convenience Kits: 1) PICC CATHETER INSERTION TRAY, Model Number: CVI4300; 2) OSC SHERMAN KNEE ARTHRO BASIC, Model Number: DYKM1977C; 3) KIT ACES INSERT PEG, Model Number: DYKMBNDL130; 4) KIT ACES INSERT PEG, Model Number: DYKMBNDL130A; 5) KIT ACES INSERT PERCUTANEOUS T, Model Number: DYKMBNDL4; 6) NICU LINE CHANGE TRAY, Model Number: LC295
Medline Convenience Kits: 1) PICC CATHETER INSERTION TRAY, Model Number: CVI4300; 2) OSC SHERMAN KNEE ARTHRO BASIC, Model Number: DYKM1977C; 3) KIT ACES INSERT PEG, Model Number: DYKMBNDL130; 4) KIT ACES INSERT PEG, Model Number: DYKMBNDL130A; 5) KIT ACES INSERT PERCUTANEOUS T, Model Number: DYKMBNDL4; 6) NICU LINE CHANGE TRAY, Model Number: LC295
Medline has identified issues related to calibration of the equipment used to sterilize and package the devices. All products were exposed to the validated sterilization and packaging cycles; however, the identified calibration issues have the potential to impact the sterility assurance level (SAL) of the Recalled Products.
FDA DevicesOne Step 10A in vitro diagnostic test
One Step 10A in vitro diagnostic test
The devices were distributed without required FDA premarket clearance or approval.
FDA DevicesMedline Convenience Kits: 1) BURN PACK, Model Number: DYNJ15668R; 2) BURN PACK-LF, Model Number: DYNJ42829B; 3) BURN CARE PACK-LF, Model Number: DYNJT3437
Medline Convenience Kits: 1) BURN PACK, Model Number: DYNJ15668R; 2) BURN PACK-LF, Model Number: DYNJ42829B; 3) BURN CARE PACK-LF, Model Number: DYNJT3437
Medline has identified issues related to calibration of the equipment used to sterilize and package the devices. All products were exposed to the validated sterilization and packaging cycles; however, the identified calibration issues have the potential to impact the sterility assurance level (SAL) of the Recalled Products.
FDA DevicesQUCARE Total Cholesterol in vitro diagnostic test REF: 6407
QUCARE Total Cholesterol in vitro diagnostic test REF: 6407
The devices were distributed without required FDA premarket clearance or approval.
FDA DevicesHalyard CATH LAB kit. Model Number: SACL75-01.
Halyard CATH LAB kit. Model Number: SACL75-01.
Potential risk for Medline syringe rotating adaptor unwinding during use, which may result in a loose connection and/or full disconnection between the syringe and manifold.
FDA DevicesHalyard CATH LAB kit. Model Number: SACL75AM.
Halyard CATH LAB kit. Model Number: SACL75AM.
Potential risk for Medline syringe rotating adaptor unwinding during use, which may result in a loose connection and/or full disconnection between the syringe and manifold.
FDA DevicesHalyard CARDIAC CATH PACK kit. Model Number: EAMC1000-05, WAFB208-02.
Halyard CARDIAC CATH PACK kit. Model Number: EAMC1000-05, WAFB208-02.
Potential risk for Medline syringe rotating adaptor unwinding during use, which may result in a loose connection and/or full disconnection between the syringe and manifold.
FDA DevicesOne Step P in vitro diagnostic test REF: 8194
One Step P in vitro diagnostic test REF: 8194
The devices were distributed without required FDA premarket clearance or approval.
FDA DevicesCentimeter Sizing Catheter RPN N5.0-35-100-P-10S-PIG-CSC-20 GPN G11916 Catheters for use in angiographic procedures are available in a variety of French sizes, endhole sizes, lengths, materials and designs (e.g., polyethylene or nylon, non-braided or braided with 1:1 torque). The choice of catheter material for different angiographic procedures should be based on the physician s experience.
Centimeter Sizing Catheter RPN N5.0-35-100-P-10S-PIG-CSC-20 GPN G11916 Catheters for use in angiographic procedures are available in a variety of French sizes, endhole sizes, lengths, materials and designs (e.g., polyethylene or nylon, non-braided or braided with 1:1 torque). The choice of catheter material for different angiographic procedures should be based on the physician s experience.
Marker bands may be at an increased risk of cracking/breakage. Potential adverse events that may result include increased procedural time, harms associated with device fragmentation/separation, and vessel injury. In a worst-case scenario, device fragmentation and separation may cause life-threatening harm or death.
FDA DevicesHalyard NEURO IR PERIPHERAL (PS 64405) kit. Model Number: UINR44-01.
Halyard NEURO IR PERIPHERAL (PS 64405) kit. Model Number: UINR44-01.
Potential risk for Medline syringe rotating adaptor unwinding during use, which may result in a loose connection and/or full disconnection between the syringe and manifold.