Z-0393-05

Weck, Endo5, Hem-o-lok ML, Ref 544965, Hem-o-lok ML Endoscopic Clip Applier, Non-Sterile Clean and sterilize...

Name: Z-0393-05 Weck, Endo5, Hem-o-lok ML, Ref 544965, Hem-o-lok ML Endoscopic Clip Applier, Non-Sterile Clean and sterilize...
Creator: Weck
Published: 2001-10-31
License: https://open.fda.gov/license/

Teleflex Medical / initiated 2001-10-31 / Terminated / root cause: manufacturing process

FDA source

Weck began a recall of Weck, Endo5, Hem-o-lok ML, Ref 544965, Hem-o-lok ML Endoscopic Clip Applier, Non-Sterile Clean and sterilize before use. Weck Closure Systems, TFX Medical... on 2001-10-31. The reason FDA records is "The flush port on some appliers was occluded with an epoxy resin during manufacturing". As of 2026-09-10, the recall status on record is Terminated, and MDM tags the root cause as manufacturing process.

Recall record

Recall number: Z-0393-05
Status: Terminated
Initiated: 2001-10-31
Posted: 2005-01-13
Terminated: 2005-01-31
Recalling firm: Teleflex Medical
Product: Weck, Endo5, Hem-o-lok ML, Ref 544965, Hem-o-lok ML Endoscopic Clip Applier, Non-Sterile Clean and sterilize before use. Weck Closure Systems, TFX Medical Ltd., Halifax Road, P.O. Box 138, High Wycombe HP123NB U.K.
Product code: GDO Applier, Surgical, Clip
Reason for recall: The flush port on some appliers was occluded with an epoxy resin during manufacturing.
Root cause tag: manufacturing process
FDA root cause: Other
Action: Consignees were notified by letter on 10/31/2001.
Quantity in commerce: 66 units
Distribution: AL, AZ, CA,CO, CT, FL,GA, KS, NC, NH, NJ, NY, TN, TX, VA,WA.Australia, Singapore, Venezuela.
Product codes and lots: Catalog #544965, Lot #694505 & 694506

Product code GDO

The FDA recall record names no cleared device, and no clearance has been matched to it.

MDM coverage of this record lists here, newest first.

About this record

Sourced from the FDA device recall database and the FDA enforcement reports, both ingested from openFDA. The recall record supplies the product, the reason and the product code; the enforcement report supplies the classification. The two datasets are exported by FDA on different days, and the date above is the older of the two, so nothing on this page is newer than it says.

MDM adds the root cause tag, derived from FDA’s own root cause text, and the cross-links to the product code, the clearances named on the record and MDM coverage. Where a recall has not been joined to an enforcement report, no classification is shown.

Data as of 2026-09-30, the FDA export date for this dataset. Page last changed 2026-09-05. View this recall on fda.gov (opens on fda.gov)