Z-2327-2016Class II

Horizon 24 Large Titanium Clips with Adhesive Backing, Ref 004204, Rx Only, Sterile. The metal ligating clips...

Name: Z-2327-2016 Horizon 24 Large Titanium Clips with Adhesive Backing, Ref 004204, Rx Only, Sterile. The metal ligating clips...
Creator: Teleflex Medical
Published: 2013-08-08
License: https://open.fda.gov/license/

Teleflex Medical / initiated 2013-08-08 / Terminated / root cause: labeling and UDI

FDA source

Teleflex Medical began a recall of Horizon 24 Large Titanium Clips with Adhesive Backing, Ref 004204, Rx Only, Sterile. The metal ligating clips are intended for use in procedures involving... on 2013-08-08. FDA classified it as Class II and gives the reason as "The manufacturing and expiration dates are not printed on the blister pack 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-2327-2016
Classification: Class II
Status: Terminated
Initiated: 2013-08-08
Posted: 2016-08-03
Terminated: 2016-08-15
Recalling firm: Teleflex Medical
Product: Horizon 24 Large Titanium Clips with Adhesive Backing, Ref 004204, Rx Only, Sterile. The metal ligating clips are intended for use in procedures involving vessels or anatomic structures for which the surgeon determines ligating clips are the best choice. An implantable clip is a clip-like device intended to connect internal tissues to aid healing. It is not absorbable
Product code: FZP Clip, Implantable
Reason for recall: The manufacturing and expiration dates are not printed on the blister pack label.
Root cause tag: labeling and UDI
FDA root cause: Error in labeling
Action: Teleflex sent an Urgent Medical Device Recall Notification dated August 8, 2013, to all affected customers. The letter requested that they quarantine the product and to return it to Teleflex. An acknowledgment form was included with the letter which also was to be returned to Teleflex. A separate letter was sent to distributors requesting they conduct a sub-recall. If you have any further questions, please call (610) 378-0131.
Quantity in commerce: 8,220 ea.
Distribution: USA Distribution to the states of :AL, AZ, CA, CT, FL, IL, KY, MD, MI, MN, NM, NY, NC, OR, PA, SC, TX, VA, WA, WI, and Internationally to Canada
Product codes and lots: Lot/Serial Number 01J1200435

Enforcement reports

One row per recalled product line

FDA enforcement reports joined to recall event Z-2327-2016
Recall number	Class	Status	Voluntary or mandated	Report date	Classified
Z-2327-2016	Class II	Terminated	Voluntary: Firm initiated	2016-08-10	2016-08-03

Product code FZP

K982313Class IIHorizon Titanium Clips, Horizon Tantalum ClipsWeck Closure Systems / cleared 1998-08-10

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)