AVID Medical Recalls Heart Prep Trays for Lubricant Contamination
AVID Medical, Inc. is recalling 96 Heart Prep Trays (Model MECV97W) 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 source identifies the hazard as potential contamination with a manufacturing lubricant and does not report any illnesses, injuries, or deaths.
Plain-English summary
AVID Medical, Inc. is recalling 96 units of the Heart Prep Tray, Model/Item Number MECV97W. The recall is due to the potential presence of a lubricant used during the manufacturing process.
The affected products were distributed nationwide in the states of Arizona, California, Florida, Maryland, Nebraska, and Texas. The specific kit lot numbers involved are 1691836 and 1696316. The recalled supplier component within the kits is identified as A319514AM with supplier lot number NGKV2393.
The source text does not provide specific instructions for consumers or healthcare facilities on how to handle the recalled items, nor does it report any illnesses, injuries, or deaths associated with the use of these products.
The recalled product
- Product
- HEART PREP TRAY; Model/Item Number (Kit): MECV97W;
- Manufacturer
- AVID Medical, Inc.
- Category
- Medical Device — Surgical Kits
- Hazard
- Affected units
- 96
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 (6)
- Model/Item Number (Kit): MECV97W
- UDI-DI: 10809160493113
- Kit Lot Numbers: 1691836
- 1696316
- Recalled Supplier Component (in kit): A319514AM
- Recalled Supplier Lot Number (in kit): NGKV2393
Distribution
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