Z-0078-2013Class II

Hem-o-lok Large Polymer Ligating Clips, REF #544240, Rx only, Sterile, Teleflex Medical, Research Triangle...

Name: Z-0078-2013 Hem-o-lok Large Polymer Ligating Clips, REF #544240, Rx only, Sterile, Teleflex Medical, Research Triangle...
Creator: Teleflex Medical
Published: 2012-09-25
License: https://open.fda.gov/license/

Teleflex Medical / initiated 2012-09-25 / Terminated / root cause: packaging

FDA source

Teleflex Medical began a recall of Hem-o-lok Large Polymer Ligating Clips, REF #544240, Rx only, Sterile, Teleflex Medical, Research Triangle Park, NC 27709. Teleflex Medicals Hem-o-lok polymer... on 2012-09-25. FDA classified it as Class II and gives the reason as "Product is being recalled due to the possibility that the tray may contain pinholes, compromising product 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-0078-2013
Classification: Class II
Status: Terminated
Initiated: 2012-09-25
Posted: 2012-10-18
Terminated: 2012-11-08
Recalling firm: Teleflex Medical
Product: Hem-o-lok Large Polymer Ligating Clips, REF #544240, Rx only, Sterile, Teleflex Medical, Research Triangle Park, NC 27709. Teleflex Medicals Hem-o-lok polymer ligating clips are single use, sterile, non-absorbable medial devices that have been designed to ligate vessels and tissue structures during various types of surgical procedures. Vessels and tissue structures in the range of 0.5 to 16 mm can be effectively ligated with Hem-o-lok clips.
Product code: FZP Clip, Implantable
Reason for recall: Product is being recalled due to the possibility that the tray may contain pinholes, compromising product sterility.
Root cause tag: packaging
FDA root cause: Packaging process control
Action: Teleflex sent a Urgent Medical Device Recall Notification dated September 25, 2012, to all affected customers. The letter identified the product the problem and the action needed to be taken by the customer. Customers were instructed to check their inventory and quarantine any affected inventory found. They were to complete the enclosed Field Corrective Action Acknowledgement Form and return it to the Teleflex Medical sales representative who will then remove the affected product from the facility and ensure its return to Teleflex Medical. We sincerely apologize for any inconvenience this action may cause your operations. If you have any questions please contact your local sales representative or Customer Service at 1-866-246-6990.
Quantity in commerce: 126 units
Distribution: Nationwide Distribution including the state of Nevada.
Product codes and lots: Catalog No. 544240, Lot #01E1200585

Enforcement reports

One row per recalled product line

FDA enforcement reports joined to recall event Z-0078-2013
Recall number	Class	Status	Voluntary or mandated	Report date	Classified
Z-0078-2013	Class II	Terminated	Voluntary: Firm initiated	2012-10-24	2012-10-18

Product code FZP

K993157Class IIHem-O-Lok Smx Polymer Clips, Model 544220, Hem-0-Lok Mlx Polymer Clips, Model 544240Weck Closure Systems / cleared 1999-12-17

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 2026-10-07, the FDA export date for this dataset. Page last changed 2026-09-05. View this recall on fda.gov (opens on fda.gov)