AVID Medical Recalls 33 Endovascular Packs Due to Lubricant Contamination
AVID Medical, Inc. is recalling 33 Endovascular Packs (Model VAPX014-04) 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 a potential contamination with a manufacturing lubricant in a Class II recall. The source does not report any illnesses, injuries, or deaths.
Plain-English summary
AVID Medical, Inc. is recalling 33 units of the Endovascular Pack, Model/Item Number (Kit) VAPX014-04. The recall is being conducted because the product may be potentially contaminated with a lubricant used during the manufacturing process.
The affected kits have UDI-DI 10809160332863 and include specific kit lot numbers 1701106, 1702175, and 1702273. The recalled supplier component within the kit is A902416, with supplier lot number NGKU4043.
These products were distributed nationwide in the United States, specifically in the states of Arizona, California, Florida, Maryland, Nebraska, and Texas. The source text does not provide specific instructions for consumers or healthcare providers 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
- ENDOVASCULAR PACK; Model/Item Number (Kit): VAPX014-04;
- Manufacturer
- AVID Medical, Inc.
- Category
- Medical Device — Endovascular
- Hazard
- Affected units
- 33
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 (7)
- 1. Model/Item Number (Kit): VAPX014-04
- UDI-DI: 10809160332863
- Kit Lot Numbers: 1701106
- 1702175
- 1702273
- Recalled Supplier Component (in kit): A902416
- Recalled Supplier Lot Number (in kit): NGKU4043
Distribution
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