Device product
Irrigation Clip 30; Intended to position and hold irrigation tubing during surgical procedures.
Z-1246-2016
Product summary
- Event
- Event 73197
- Status
- Terminated
- Classification
- Class II
- Quantity
- 50 clips
- Official record key
device-enforcement:Z-1246-2016
Official wording
Reason: Assembled with the incorrect (smaller) front clips (component 44-0495 instead of 44.0498).
Code information: Model/Catalog: IRR-Clip-30 Lot # J023101962
Distribution pattern: Distributed in the states of PA and MN, and the country of Switzerland.
Derived failure modes
-
Unknown
Assembled with the incorrect (smaller) front clips (component 44-0495 instead of 44.0498).