Recall Z-2312-2017— Cook Inc.
Class II · Terminated
Class II FDA medical device recall by Cook Inc., initiated 2017-05-01, terminated 2019-03-26. FDA's recall record names no specific 510(k) clearance for this event. 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.. Reason: 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..
- Recalling firm
- Cook Inc.
- Classification
- Class II
- Status
- Terminated
- Initiated
- 2017-05-01
- Terminated
- 2019-03-26
- Firm location
- Bloomington, IN, United States
Product description
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.
Reason for recall
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.
Data sourced from openFDA. This site is unofficial and independent of the FDA.