Recall record at a glance
| Official record | Z-2311-2017 |
|---|---|
| Category | Medical Device Recalls |
| Classification | Class II |
| FDA record status | Terminated |
| Recalling firm | Cook Inc. |
| Report date | Jun 14, 2017 |
| Recall initiation date | May 1, 2017 |
| Quantity | 327 lots |
| Location | Bloomington, IN, United States |
Official product description
Willscher Vas Skewers, Surgical Instrument, Supplied sterilized by ethylene oxide gas in peel-open packages. Used to stabilize the vas ends during microscopic vasovasostomy.
Why the product was recalled
COOK Medical is initiating a voluntary recall of multiple products because the reprocessing instructions do not provide sufficient detailed information for the cleaning, disinfection, and sterilization of these products.
Distribution information
Worldwide Distribution - US (nationwide) and countries of: Australia, Austria, Belgium, Bahrain, Canada, China, Costa Rica, Finland, France, Germany, Hong Kong, India, Ireland, Italy, Lithuania, Latvia, Malaysia, Netherlands, Romania, Russia, Saudi Arabia, Singapore, Spain, Switzerland, United Arab Emirates, and United Kingdom.
How to read the classification
FDA Class II indicates a situation in which use of or exposure to the product may cause temporary or medically reversible adverse health consequences, or where the probability of serious consequences is remote. The classification shown here comes from the FDA record.
Additional record details
Recall type: Voluntary: Firm initiated. Initial notification: Letter.
What to do next
If you believe you have the recalled product, use the recall number and firm information above to confirm the official notice and follow the instructions issued by the FDA, recalling firm, retailer or product manufacturer. For drugs and medical devices, decisions about treatment or medical care should be discussed with a qualified health professional.
About this record
Recall Lookup USA preserves the most complete source information successfully retrieved. We do not create missing facts or infer affected lots or VINs. The official record may still change, so use the identifier above when verifying current instructions.
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