Cook Medical Recalls Willscher Vas Reapproximator Sets Due to Reprocessing Instructions
Cook Medical is voluntarily recalling Willscher Vas Reapproximator Sets because the reprocessing instructions lack sufficient detail for proper cleaning, disinfection, and sterilization.
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 FDA Class II and is voluntary, driven by a documentation deficiency in reprocessing instructions rather than a reported injury or contamination event.
Plain-English summary
Cook Medical is initiating a voluntary recall of the Willscher Vas Reapproximator Set, a surgical instrument used to stabilize vas ends during microscopic vasovasostomy. The product is supplied sterilized by ethylene oxide gas in peel-open packages.
The recall is being conducted because the reprocessing instructions provided with the product do not contain sufficient detailed information for the cleaning, disinfection, and sterilization of the instruments. This deficiency could impact the safety of the device if it is reprocessed for reuse.
The recall involves 327 lots and 364 units manufactured between January 2012 and March 2016. These products were distributed worldwide, including in the United States and numerous international markets. Healthcare facilities and users should stop using the affected products and contact Cook Medical for further instructions.
The recalled product
- Product
- Willscher Vas Reapproximator Set, Surgical Instrument, Supplied sterilized by ethylene oxide gas in peel-open packages. Used to stabilize the vas ends during microscopic vasovasostomy.
- Manufacturer
- Cook Inc.
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 (3)
- CATALOG NUMBER: 092000
- GPN: G14500
- Dates of Manufacture: January 2012 to March 2016
Distribution
Distributed nationwide across the United States.
Part of a larger recall action
This product is one of 6 recalled by Cook Inc. under a single FDA (Devices) recall action. The agency files each product separately, so the size of the action is not visible from this page alone.
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