Z-0826-2015Class II

WECK Hemoclip Traditional Medium Tantalum Ligating Clips. Weck Ligating Clips are intended for use in...

Name: Z-0826-2015 WECK Hemoclip Traditional Medium Tantalum Ligating Clips. Weck Ligating Clips are intended for use in...
Creator: Teleflex Medical
Published: 2014-12-03
License: https://open.fda.gov/license/

Teleflex Medical / initiated 2014-12-03 / Terminated / root cause: labeling and UDI

FDA source

Teleflex Medical began a recall of WECK Hemoclip Traditional Medium Tantalum Ligating Clips. Weck Ligating Clips are intended for use in procedures involving vessels or anatomic structures for... on 2014-12-03. FDA classified it as Class II and gives the reason as "The manufacturing dates and expiration dates were transposed on the Tyvek 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-0826-2015
Classification: Class II
Status: Terminated
Initiated: 2014-12-03
Posted: 2014-12-17
Terminated: 2017-11-24
Recalling firm: Teleflex Medical
Product: WECK Hemoclip Traditional Medium Tantalum Ligating Clips. Weck Ligating Clips are intended for use in procedures involving vessels or anatomic structures for which the surgeon determines ligating clips are the best choice.
Product code: FZP Clip, Implantable
Reason for recall: The manufacturing dates and expiration dates were transposed on the Tyvek label.
Root cause tag: labeling and UDI
FDA root cause: Labeling Change Control
Action: Consignees were notified by letter on 12/03/2014.
Quantity in commerce: 3180 units
Distribution: US (nationwide) including the states of AL, CA, FL, DE, IA, IL, IN, KY, MA, MN, NC, NE, NJ, NY, NV, OH, OK, PA, TX, VA, VT, and WA.
Product codes and lots: Product Code: 523300, Lot number: 01B1400034

Enforcement reports

One row per recalled product line

FDA enforcement reports joined to recall event Z-0826-2015
Recall number	Class	Status	Voluntary or mandated	Report date	Classified
Z-0826-2015	Class II	Terminated	Voluntary: Firm initiated	2014-12-24	2014-12-17

Product code FZP

K800079Class IIHemoclip Surgical Occluding ClipEdward Weck, Inc. / cleared 1980-01-28

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 2026-10-14, the FDA export date for this dataset. Page last changed 2026-09-05. View this recall on fda.gov (opens on fda.gov)