AVID Medical Recalls 23 ABD Hysterectomy Kits Due to Lubricant Contamination
AVID Medical, Inc. is recalling 23 ABD Hysterectomy kits (Model NAMC438-07) 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 as the hazard. The source does not report any illnesses, injuries, or deaths.
Plain-English summary
AVID Medical, Inc. is recalling 23 units of the ABD Hysterectomy kit, Model/Item Number NAMC438-07. The recall is due to the potential for contamination with a lubricant used during the manufacturing process. The affected kits include specific lot numbers 1675123, 1675125, and 1679551, and contain a recalled supplier component (A119216M) with lot number NGKT2404.
The FDA has classified this as a Class II recall. The affected products were distributed nationwide in the states of Arizona, California, Florida, Maryland, Nebraska, and Texas. The source text does not report any illnesses, injuries, or deaths associated with this recall.
Healthcare providers and consumers should stop using the affected kits and contact AVID Medical, Inc. for further instructions or a return.
The recalled product
- Product
- ABD HYSTERECTOMY; Model/Item Number (Kit): NAMC438-07;
- Manufacturer
- AVID Medical, Inc.
- Category
- Medical Device — Surgical Kits
- Hazard
- Affected units
- 23
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 (7)
- Model/Item Number (Kit): NAMC438-07
- UDI-DI: 10809160417645
- Kit Lot Numbers: 1675123
- 1675125
- 1679551
- Recalled Supplier Component (in kit): A119216M
- Recalled Supplier Lot Number (in kit): NGKT2404
Distribution
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