—#155462

Product

Clarke-Reich Laparoscopic Knot Pusher

FDA product code: NWV — Laparoscopic Accessories, Gynecologic
Device class: Class 1
Medical specialty: Obstetrics/Gynecology
Affected lot / code info: All lots Catalog numbers: J-CRKP-042900

Why it was recalled

reprocessing instructions do not provide sufficient detailed information for the cleaning, disinfection, and sterilization of these products

Root cause (FDA determination)

Labeling design

Action the firm took

On 4/25/2017, URGENT: MEDICAL DEVICE RECALL notifications were sent to the affected consignees via courier. The recall notification included a description of the reason for the recall, affected product, consignee responsibilities, and instructions for responding to the formal recall notification.

Recalling firm

Firm: Cook Inc.
Address: 750 N Daniels Way, Bloomington, Indiana 47404-9120

Distribution

Distribution pattern: The devices have been distributed nationwide within the United States and the following countries: Australia, Belgium, Canada, Finland, Germany, Guatemala, Hong Kong, India, Ireland, Japan, South Korea, Kuwait, Malaysia, Netherlands, New Zealand, Puerto Rico, Saudi Arabia, Taiwan, and the United Kingdom.

Timeline

Recall initiated: 2017-04-25
Terminated: 2019-03-26
Status: —

Source: openFDA Device Recall endpoint. Recall record ID #155462. The FDA issues recall classifications as health-hazard assessments, not legal findings; for legal claims consult a licensed attorney.