Official recall notice
FDA DeviceClass IINotable
Pack Open Heart CFH Recall (Oct 2026) – AVID Medical
Product: PACK OPEN HEART CFH; Model/Item Number (Kit): 1. UFCF004-06, 2. UFCF004-07;
- Recall date
- 2026-10-14
- Brand
- AVID Medical, Inc.
- Category
- Medical Device
- FDA class
- Class II
Why it was recalled
Hazard
Product may be potentially contaminated with a lubricant used during the manufacturing process.
Product description
Product may be potentially contaminated with a lubricant used during the manufacturing process.
Affected products
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;