Cook Medical Recalls Willscher Vas Reapproximator Plates Due to Reprocessing Instructions
Cook Medical is voluntarily recalling Willscher Vas Reapproximator Plates because the reprocessing instructions lack sufficient detail for 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: This is a voluntary precautionary recall involving a documentation issue (insufficient reprocessing instructions) without reported injuries or illnesses, fitting the Moderate severity criteria.
Plain-English summary
Cook Medical is initiating a voluntary recall of Willscher Vas Reapproximator Plates. These surgical instruments are supplied sterilized by ethylene oxide gas in peel-open packages and are used to stabilize the vas ends during microscopic vasovasostomy. The recall involves 327 lots with catalog numbers 092002 and 096511.
The reason for the recall is that the reprocessing instructions do not provide sufficient detailed information for the cleaning, disinfection, and sterilization of these products. The device was obsoleted on April 30, 2008.
The products were distributed worldwide, including the United States and numerous international locations such as Australia, Canada, China, Germany, and the United Kingdom. Healthcare facilities and users should stop using the affected lots and contact Cook Medical for further instructions.
The recalled product
- Product
- Willscher Vas Reapproximator Plate, 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: 092002 and 096511
- GPN: G15612 and G15573
- 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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