Cook Medical Recalls Willscher Vas Skewers Due to Insufficient Reprocessing Instructions
Cook Medical is voluntarily recalling Willscher Vas Skewers because the provided instructions do not contain 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 involves a voluntary precautionary measure regarding labeling/instruction deficiencies without reported injuries or illnesses, fitting the Moderate severity criteria.
Plain-English summary
Cook Medical is initiating a voluntary recall of Willscher Vas Skewers, a surgical instrument used to stabilize vas ends during microscopic vasovasostomy. The recall is being conducted because the reprocessing instructions supplied with the device do not provide sufficient detailed information for the cleaning, disinfection, and sterilization of the product.
The affected products were supplied sterilized by ethylene oxide gas in peel-open packages. The recall covers 327 lots of the device, identified by Catalog Number 092001 and GPN G14512. The device was obsoleted on April 30, 2008.
Distribution was worldwide, including the United States (nationwide) and numerous international locations such as Australia, Canada, China, Germany, India, and the United Kingdom. Healthcare facilities and users should stop using the affected devices and contact Cook Medical for further instructions regarding the recall.
The recalled product
- Product
- Willscher Vas Skewers, Surgical Instrument, Supplied sterilized by ethylene oxide gas in peel-open packages. Used to stabilize the vas ends during microscopic vasovasostomy.
- Manufacturer
- Cook Inc.
- Affected units
- 327
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: 092001
- GPN: G14512
- The device was obsoleted on 04/30/2008
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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