Z-1388-04

Ref. No. 523171 Hemoclip, 10 Large Tantalum Clips/Cartridge (Non-Sterile) and Ref. No. 523371 Hemoclip, 15...

Name: Z-1388-04 Ref. No. 523171 Hemoclip, 10 Large Tantalum Clips/Cartridge (Non-Sterile) and Ref. No. 523371 Hemoclip, 15...
Creator: Weck
Published: 2003-10-24
License: https://open.fda.gov/license/

Teleflex Medical / initiated 2003-10-24 / Terminated / root cause: packaging

FDA source

Weck began a recall of Ref. No. 523171 Hemoclip, 10 Large Tantalum Clips/Cartridge (Non-Sterile) and Ref. No. 523371 Hemoclip, 15 Large Tantalum Clips/Cartridge (Non-Sterile) on 2003-10-24. The reason FDA records is "Hole in the sterile unit blister pack that could compromise sterility". As of 2026-09-10, the recall status on record is Terminated, and MDM tags the root cause as packaging.

Recall record

Recall number: Z-1388-04
Status: Terminated
Initiated: 2003-10-24
Posted: 2004-08-24
Terminated: 2004-08-25
Recalling firm: Teleflex Medical
Product: Ref. No. 523171 Hemoclip, 10 Large Tantalum Clips/Cartridge (Non-Sterile) and Ref. No. 523371 Hemoclip, 15 Large Tantalum Clips/Cartridge (Non-Sterile)
Product code: HBT Applier, Hemostatic Clip
Reason for recall: Hole in the sterile unit blister pack that could compromise sterility.
Root cause tag: packaging
FDA root cause: Other
Action: The consignees were notified of the recall via letter beginning October 24, 2003 asking for return of the product.
Quantity in commerce: 91,869 units for all products under recall
Distribution: Nationwide and to accounts in Canada, Europe Asia, and South/Latin America
Product codes and lots: All lots manufactured between 2001-8 through 2002-12 for the 10 and 15 Large Tantalum Clips and lot 763013 for the 15 Large Tantalum Clips

Product code HBT

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)