medical MODERATE Updated 2026-10-14

AVID Medical, Inc. recalls PACK OPEN HEART CFH; Model/Item Number (Kit): 1. UFCF004-06

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Recalled Product

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

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Hazard / Issue

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

Issued by

FDA

Distribution: Nationwide (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;

✅ What Should You Do?

  1. 1Contact your healthcare provider immediately to discuss this recall.
  2. 2Stop using the device if it is safe to do so, and contact your provider.
  3. 3Follow the manufacturer's remedy instructions provided in the recall notice.
  4. 4Report device problems to FDA MedWatch or call 1-800-FDA-1088.

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