AVID Medical Recalls 15 Laparoscopic Prostatectomy Kits for Lubricant Contamination
AVID Medical, Inc. is recalling 15 laparoscopic prostatectomy kits 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 15 units of the Laparoscopic Prostatectomy kit, Model/Item Number NIHB0036-07. The recall is due to the potential presence of 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 1657751, and the recalled supplier component within the kit is A942216 with supplier lot number NGKT3375.
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 kits.
The recalled product
- Product
- LAPAROSCOPIC PROSTATECTOMY; Model/Item Number (Kit): NIHB0036-07;
- Manufacturer
- AVID Medical, Inc.
- Category
- Medical Device — Surgical Kits
- Hazard
- Affected units
- 15
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): NIHB0036-07
- UDI-DI: 10809160403099
- Kit Lot Numbers: 1657751
- Recalled Supplier Component (in kit): A942216
- Recalled Supplier Lot Number (in kit): NGKT3375
Distribution
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