Avid Medical Recalls Robotic Prostatectomy Packs for Lubricant Contamination
Avid Medical, Inc. is recalling six Robotic Prostatectomy Packs (NAMC423-11) because they may be contaminated with a manufacturing lubricant.
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 FDA classified this as a Class II recall because the product may be contaminated with a manufacturing lubricant. The source does not report any illnesses, injuries, or deaths.
Plain-English summary
Avid Medical, Inc. is recalling six units of the Robotic Prostatectomy Pack, Model/Item Number (Kit) NAMC423-11. The recall is due to a potential contamination with a lubricant used during the manufacturing process.
The affected kits were distributed nationwide in Arizona, California, Florida, Maryland, Nebraska, and Texas. The specific kit lot number is 1671502. The recalled supplier component within the kit is A119216M, with supplier lot number NGKT2404.
The source text does not provide specific instructions for consumers or healthcare providers on how to handle the recalled product, nor does it report any illnesses, injuries, or deaths associated with the use of these packs.
The recalled product
- Product
- ROBOTIC PROSTATECTOMY PACK; Model/Item Number (Kit): NAMC423-11;
- Manufacturer
- AVID Medical, Inc.
- Category
- Medical Device — Surgical Kits
- Hazard
- Affected units
- 6
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)
- Model/Item Number (Kit): NAMC423-11
- UDI-DI: 10809160490808
- Kit Lot Numbers: 1671502
- Recalled Supplier Component (in kit): A119216M
- Recalled Supplier Lot Number (in kit): NGKT2404
Distribution
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