Class IIDeviceOngoing

AVID Medical, Inc.

PACK OPEN HEART CFH; Model/Item Number (Kit): 1. UFCF004-06, 2. UFCF004-07;

Reason for recall

Product may be potentially contaminated with a lubricant used during the manufacturing process.

Details

Recall number: Z-0097-2027
Event ID: 99808
Recall initiated: Aug 10, 2026
Classified: Oct 7, 2026
Reported: Oct 14, 2026
Quantity: 124
Distribution: US Nationwide distribution in the states of AZ, CA, FL, MD, NE, TX.
Initiated by: Voluntary: Firm initiated
Firm notification: E-Mail
Firm location: Toano, VA, United States
Lot / code info: 1. Model/Item Number (Kit): UFCF004-06; UDI-DI: 10809160487334; Kit Lot Numbers: 1666214, 1672814; 2. Model/Item Number (Kit): UFCF004-07; UDI-DI: 10809160513170; Kit Lot Numbers: 1695181; Recalled Supplier Component (in kit): A119216M; Recalled Supplier Lot Number (in kit): NGKT2404, NGKT3314;