Z-0097-2027 Class II Ongoing
FDA device recall Z-0097-2027 was initiated by AVID Medical, Inc. on Aug 10, 2026 and is designated Class II. Reason for recall: Product may be potentially contaminated with a lubricant used during the manufacturing process. The recall status is ongoing. Affected quantity: 124.
Recall Details
- Product Type
- Devices
- Report Date
- Oct 14, 2026
- Initiation Date
- Aug 10, 2026
- Voluntary/Mandated
- Voluntary: Firm initiated
- Product Quantity
- 124
Product Description
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.
Distribution Pattern
US Nationwide distribution in the states of AZ, CA, FL, MD, NE, TX.
Code Information
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;
Source
- Dataset
- openFDA device recall enforcement reports
- FDA record
- This recall in openFDA (JSON)
- Enforcement Report
- Search FDA's Enforcement Report for Z-0097-2027
- openFDA file date
- Oct 23, 2026
- Loaded by RegDataLab
- Oct 24, 2026