Weck, Endo5, Hem-o-lok ML, Ref 544965, Hem-o-lok ML Endoscopic Clip Applier, Non-Sterile Clean and sterilize before use.
FDA device recall Z-0393-05 · posted 2005-01-13 · Terminated
Recall details
- Recalling firm
- Weck
- Reason for recall
- The flush port on some appliers was occluded with an epoxy resin during manufacturing.
- Action taken
- Consignees were notified by letter on 10/31/2001.
- Root cause
- Other
- Status
- Terminated
- Product code
- GDO
- Quantity affected
- 66 units
- Distribution
- AL, AZ, CA,CO, CT, FL,GA, KS, NC, NH, NJ, NY, TN, TX, VA,WA.Australia, Singapore, Venezuela.
- Date initiated
- 2001-10-31
- Date posted
- 2005-01-13
- Date terminated
- 2005-01-31
- Location
- Research Triangle Park, NC
Monitor recalls programmatically
Recalls and clearances share one API, with change alerts when new recalls post.