AVID Medical Recalls GYN Laparoscopy Kits for Potential Lubricant Contamination
AVID Medical, Inc. is recalling 134 GYN Laparoscopy/Laparotomy kits due to potential contamination 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 source identifies a potential contamination with a manufacturing lubricant as the hazard. The source does not report any illnesses, injuries, or deaths.
Plain-English summary
AVID Medical, Inc. is recalling 134 units of GYN Laparoscopy/Laparotomy kits. The affected kits include Model/Item Numbers WRNM002-15 and FBCH108-03. The recall is being conducted because the products may be potentially contaminated with a lubricant used during the manufacturing process.
The recalled products were distributed nationwide in the states of Arizona, California, Florida, Maryland, Nebraska, and Texas. Specific lot numbers for the kits include 1666722, 1659079, and 1696378. The recalled supplier component is identified as A942216 with supplier lot numbers NGKU3975 and NGKU2887.
Healthcare facilities and consumers should stop using these specific kits and contact AVID Medical, Inc. for further instructions or a replacement.
The recalled product
- Product
- GYN LAPAROSCOPY/LAPAROTOMY; Model/Item Number (Kit): 1. WRNM002-15, 2. FBCH108-03;
- Manufacturer
- AVID Medical, Inc.
- Category
- Medical Device — Surgical Kits
- Hazard
- Affected units
- 134
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 (10)
- 1. Model/Item Number (Kit): WRNM002-15
- UDI-DI: 10809160487181
- Kit Lot Numbers: 1666722
- 2. Model/Item Number (Kit): FBCH108-03
- UDI-DI: 10809160399781
- Kit Lot Numbers: 1659079
- 1696378
- Recalled Supplier Component (in kit): A942216
- Recalled Supplier Lot Number (in kit): NGKU3975
- NGKU2887
Distribution
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