CLASS II Device recall · Reported 14 Sep 2016 · FDA Enforcement Report

WECK¿ Horizon" Manual-Load Ligating Clip Applier recalled

Teleflex Medical is recalling WECK¿ Horizon" Manual-Load Ligating Clip Applier, For Medium-Large Size Horizon Ligation, distributed nationwide in the US. The recall was initiated on 24 Aug 2016 and the FDA has classified it as Class II.

Check your package

Lot, batch or date codesProduct Code: 337111, Lot Number: 06F1515745.

Quantity recalled49 units

Stop using the device if the notice says to, and contact the manufacturer or your healthcare provider for the correction or replacement.

Recall details

Recall number: Z-2759-2016
FDA event ID: 75020
Recalling firm: Teleflex Medical, Research Triangle Park, NC
Classification: Class II
Status: Terminated
Recall initiated: 24 Aug 2016
FDA classified: 8 Sep 2016
Reported: 14 Sep 2016
Type: Voluntary: Firm initiated
Customers notified by: Letter
Reason category: Labeling Errors
Device type: Other Medical Devices

Timeline

24 Aug 2016	Recall initiated by company
8 Sep 2016	Classified by FDA	+15 days
14 Sep 2016	Published in enforcement report	+6 days

Companies usually start a recall weeks before the FDA classifies and publishes it; the gap above is that lag.

Reason for recall

Misbranded: Incorrect etching on the device.

Product as listed by the FDA

WECK¿ Horizon" Manual-Load Ligating Clip Applier, For Medium-Large Size Horizon Ligation Clips Curved Jaw, 11 (28cm), Rx Only, REF 337111, Product Usage: Weck Closure Systems applier has been designed and calibrated for use with specific Horizon, Hemoclip Plus Hemoclip Traditional, or Atrauclip ligating clips as indicated. Applier color coding matches the color of the ligating clip cartridge for which it is to be used. Hemoclip Plus appliers are easily identified by one black-ring handle.

Where it was distributed

Worldwide Distribution US Nationwide in the states of FL, IL, KY, MI, NY and OK and countries of Mexico and Canada.

Nationwide Florida Illinois Kentucky Michigan New York Oklahoma

Questions about this recall

Why was it recalled?

Misbranded: Incorrect etching on the device.

Which lots are affected?

Product Code: 337111, Lot Number: 06F1515745.

Where was it sold?

Worldwide Distribution US Nationwide in the states of FL, IL, KY, MI, NY and OK and countries of Mexico and Canada.

What should I do if I have it?

Stop using the device if the notice says to, and contact the manufacturer or your healthcare provider for the correction or replacement.

What does Class II mean?

Class II means the product may cause temporary or medically reversible health problems, or the probability of serious harm is remote.

Read the official FDA notice · Source record retrieved 26 Sep 2026. The FDA describes openFDA data as unvalidated; the official notice takes precedence. This page reports the record and gives no medical advice.

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