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TemporaryFDAOngoing

Can cause harm that is usually temporary.

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

Check the device or its packaging for

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;
Why
Product may be potentially contaminated with a lubricant used during the manufacturing process.
Distributed
US Nationwide distribution in the states of AZ, CA, FL, MD, NE, TX.
Company
AVID Medical, Inc.
Announced
This is the date the recall was announced. A company may have started it weeks earlier.
Recall began

Source: FDA record Z-0097-2027 · retrieved 7 October 2026

Read the official notice

Every recall is shown word for word from the FDA and USDA, with a link to the source.

Local Recall