Device product
Blunt Hurd Cannula Blunt Tip 10 mm with 5 mm Reducer simplifies open laparoscopy.
Z-0147-2015
Product summary
- Event
- Event 69446
- Status
- Terminated
- Classification
- Class II
- Quantity
- 90 units
- Official record key
device-enforcement:Z-0147-2015
Official wording
Reason: CooperSurgical is recalling two lots of 900-863 because the wrong package insert (IFU) was placed into the shipper.
Code information: Lots 149460 and 149911
Distribution pattern: Worldwide Distribution: US (nationwide) to North Carolina; and Internationally to Australia and Italy.
Derived failure modes
-
Labeling or packaging
wrong package