AVID Medical Recalls Craniotomy Packs Due to Potential Lubricant Contamination
AVID Medical, Inc. is recalling 10 Craniotomy Packs (Model WRNM035-20) 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 due to potential contamination with a manufacturing lubricant. The source does not report any illnesses, injuries, or deaths.
Plain-English summary
AVID Medical, Inc. is recalling 10 units of the Craniotomy Pack, Model/Item Number WRNM035-20. The recall is due to the potential contamination of the product with 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 number is 1695943, and the recalled supplier component within the kit is A319516AM with supplier lot number NGKT2391.
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
- CRANIOTOMY PACK; Model/Item Number (Kit): WRNM035-20;
- Manufacturer
- AVID Medical, Inc.
- Category
- Medical Device — Surgical Kits
- Hazard
- Affected units
- 10
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 (5)
- 1. Model/Item Number (Kit): WRNM035-20
- UDI-DI: 10809160489277
- Kit Lot Numbers: 1695943
- Recalled Supplier Component (in kit): A319516AM
- Recalled Supplier Lot Number (in kit): NGKT2391
Distribution
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