Z-0547-04

Hem-o-LokSMX Legating Clip, REF 544220, Lot 988384, Non-absorbable Polymer Ligation Clips, Sterile EO, Weck...

Name: Z-0547-04 Hem-o-LokSMX Legating Clip, REF 544220, Lot 988384, Non-absorbable Polymer Ligation Clips, Sterile EO, Weck...
Creator: Weck
Published: 2004-01-23
License: https://open.fda.gov/license/

Teleflex Medical / initiated 2004-01-23 / Terminated

FDA source

Weck began a recall of Hem-o-LokSMX Legating Clip, REF 544220, Lot 988384, Non-absorbable Polymer Ligation Clips, Sterile EO, Weck Closure Systems, Research Triangle Park, NC 27709... on 2004-01-23. The reason FDA records is "Malformation of the Hem-o-lok SMX clip". As of 2026-09-10, the recall status on record is Terminated.

Recall record

Recall number: Z-0547-04
Status: Terminated
Initiated: 2004-01-23
Posted: 2004-02-25
Terminated: 2004-05-11
Recalling firm: Teleflex Medical
Product: Hem-o-LokSMX Legating Clip, REF 544220, Lot 988384, Non-absorbable Polymer Ligation Clips, Sterile EO, Weck Closure Systems, Research Triangle Park, NC 27709, Sterile, Single use, Disposable.
Product code: FZP Clip, Implantable
Reason for recall: Malformation of the Hem-o-lok SMX clip.
FDA root cause: Other
Action: Consignees were notified by letter via Federal Express (Domestic consignees), Email (International and Weck Sales Representatives), and Fax (Weck Sales Representatives) beginning 01/23/2004.
Quantity in commerce: 70 sales units
Distribution: Distributors and hospitals in AL, CA, FL, MA, MD, MI, NC, NY, OH, OR, PA, SC, TX, Korea and France
Product codes and lots: Catalog number 544220, Lot number 988384

Product code FZP

K982941Class IIHem-O-Lok Model Numbers 523900, 523970Weck Closure Systems / cleared 1998-11-19

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)