Avid Medical Recalls Open Heart Kits Due to Lubricant Contamination
Avid Medical is recalling 124 Open Heart CFH kits because they may be contaminated with a lubricant used during manufacturing.
The agency’s classification
FDA (Devices): Class II
Class II is a situation in which use of or exposure to a violative product may cause temporary or medically reversible adverse health consequences, or where the probability of serious adverse health consequences is remote.
This is the agency’s own classification, taken from its notice. The severity score below is our assessment, not the agency’s. How recall classes work
What this means for you
Our assessment, not the agency’s: severity 2/5 (Moderate).
Minor labeling or packaging issue, or a voluntary precautionary recall. Risk of harm is low but real — follow the manufacturer's instructions.
Our severity reasoning: The recall is classified as Class II because the product may be contaminated with a lubricant used during manufacturing. The source does not report any illnesses, injuries, or deaths.
Plain-English summary
Avid Medical, Inc. is recalling 124 units of the PACK OPEN HEART CFH kits, specifically models UFCF004-06 and UFCF004-07. The recall is being conducted because the product may be potentially contaminated with a lubricant used during the manufacturing process.
The affected kits were distributed nationwide in the United States, specifically in the states of Arizona, California, Florida, Maryland, Nebraska, and Texas. The recall includes specific kit lot numbers 1666214, 1672814, and 1695181, as well as recalled supplier components with lot numbers NGKT2404 and NGKT3314.
The source text does not report any illnesses, injuries, or deaths associated with this recall. Consumers and healthcare facilities should stop using the affected kits and contact Avid Medical, Inc. for further instructions on how to return or dispose of the product.
The recalled product
- Product
- PACK OPEN HEART CFH; Model/Item Number (Kit): 1. UFCF004-06, 2. UFCF004-07;
- Manufacturer
- AVID Medical, Inc.
- Category
- Medical Device — Surgical Kits
- Hazard
- Affected units
- 124
Is your product affected?
Check your packaging against the codes below. If any of them match, the product is part of this recall.
Lot numbers (10)
- 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
Distribution
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