Device product
Auto Endo5 Hem-o-lok Automatic Clip Applier, Medium Large Polymer Clips, Rx Only, Sterile, REF 543965 Product Usage: The Weck Auto Endo5 hem-o-lok ML automatic endoscopic ligating clip appliers are indicated for use as delivery devices for Hem-o-lok ML non-absorbable polymer ligating clips. These appliers are designed for use with 5/5.5mm cannulas. Hem-o-lok Ligating Clips are intended for use in procedures involving ligation of vessels or tissue structures.
Z-0886-2016
Product summary
- Firm
- Teleflex Medical
- Event
- Event 73181
- Status
- Terminated
- Classification
- Class II
- Quantity
- 543 ea.
- Official record key
device-enforcement:Z-0886-2016
Official wording
Reason: The clip in the applier may be missing a boss. A boss is the part of the clip that is used to hold the clip within the applier jaws prior to application.
Code information: 73J1500065, 73J1500066, 73J1500280, 73J1500440, 73J1500565, 73J1500566, 73K1500193
Distribution pattern: Worldwide Distribution in the state of CA, MI, NC, PA, TX, VA, and the countries of Canada, Korea & Belgium
Derived failure modes
-
Unknown
The clip in the applier may be missing a boss. A boss is the part of the clip that is used to hold the clip within the applier jaws prior to application.