AVID Medical Recalls GYN Laparoscopy Packs Due to Lubricant Contamination
AVID Medical, Inc. is recalling 28 GYN Laparoscopy Packs (Model NAMC436-12) 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 28 units of the GYN Laparoscopy Pack, Model/Item Number NAMC436-12. The recall is due to the potential for the product to be contaminated with a lubricant used during the manufacturing process.
The affected products were distributed nationwide in Arizona, California, Florida, Maryland, Nebraska, and Texas. The specific kit lot number is 1697826, and the recalled supplier component within the kit is A119216M with supplier lot number NGKT3314.
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
- GYN LAPAROSCOPY PACK; Model/Item Number (Kit): NAMC436-12;
- Manufacturer
- AVID Medical, Inc.
- Hazard
- Affected units
- 28
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): NAMC436-12
- UDI-DI: 10809160468470
- Kit Lot Numbers: 1697826
- Recalled Supplier Component (in kit): A119216M
- Recalled Supplier Lot Number (in kit): NGKT3314
Distribution
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