Z-2538-2016Class II

Weck EFx Classic Fascial Closure System, Rx Only, Sterile, The product is intended to facilitate placement...

Name: Z-2538-2016 Weck EFx Classic Fascial Closure System, Rx Only, Sterile, The product is intended to facilitate placement...
Creator: Teleflex Medical
Published: 2016-03-24
License: https://open.fda.gov/license/

Teleflex Medical / initiated 2016-03-24 / Terminated / root cause: labeling and UDI

FDA source

Teleflex Medical began a recall of Weck EFx Classic Fascial Closure System, Rx Only, Sterile, The product is intended to facilitate placement and withdrawal of suture loops to repair port side... on 2016-03-24. FDA classified it as Class II and gives the reason as "Incorrect expiration date was printed on the product label". As of 2026-09-10, the recall status on record is Terminated, and MDM tags the root cause as labeling and UDI.

Recall record

Recall number: Z-2538-2016
Classification: Class II
Status: Terminated
Initiated: 2016-03-24
Posted: 2016-08-15
Terminated: 2020-09-25
Recalling firm: Teleflex Medical
Product: Weck EFx Classic Fascial Closure System, Rx Only, Sterile, The product is intended to facilitate placement and withdrawal of suture loops to repair port side defects following laparoscopic surgery
Product code: HCF Instrument, Ligature Passing And Knot Tying
Reason for recall: Incorrect expiration date was printed on the product label.
Root cause tag: labeling and UDI
FDA root cause: Unknown/Undetermined by firm
Action: Teleflex sent an Urgent Medical Device Recall Notification letter dated March 24, 2016, to all affected consignees. The letter requested that consignees check their stock, immediately discontinue use and quarantine any products. To return affected product consignees were instructed to complete the enclosed Recall Acknowledgement Form and fax it to 1-855-419-8507, ATTN: Customer Service or email to [email protected]. Customers with questions were instructed to contact their local sales representative or Customer Service at 1-866-246-6990. For questions regarding this recall call 610-378-0131.
Quantity in commerce: 45
Distribution: Nationwide Distribution to CA, CO, IA, KS, MD, MI, NY, NC, PA
Product codes and lots: Product Code EFXCT1 - Lot/Batch Nos. ML-000342, ML-000343, ML-000344, ML-000348, ML-000349; Product Code EFXSP1 - Lot/Batch Nos. ML-000345, ML-000347

Enforcement reports

One row per recalled product line

FDA enforcement reports joined to recall event Z-2538-2016
Recall number	Class	Status	Voluntary or mandated	Report date	Classified
Z-2538-2016	Class II	Terminated	Voluntary: Firm initiated	2016-08-24	2016-08-15

Product code HCF

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)