CLASS II Device recall · Reported 14 Jun 2017 · FDA Enforcement Report

Willscher Vas Reapproximator Set, Surgical Instrument recalled by Cook

Cook is recalling Willscher Vas Reapproximator Set, Surgical Instrument, Supplied sterilized by ethylene, distributed nationwide in the US. The recall was initiated on 1 May 2017 and the FDA has classified it as Class II.

Check your package

Lot, batch or date codesCATALOG NUMBER: 092000, GPN: G14500, Dates of Manufacture: January 2012 to March 2016,

Quantity recalled327 lots, 364 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-2310-2017
FDA event ID: 77167
Recalling firm: Cook, Bloomington, IN
Classification: Class II
Status: Terminated
Recall initiated: 1 May 2017
FDA classified: 7 Jun 2017
Reported: 14 Jun 2017
Type: Voluntary: Firm initiated
Customers notified by: Letter
Reason category: Sterility
Device type: Surgical Instruments

Timeline

1 May 2017	Recall initiated by company
7 Jun 2017	Classified by FDA	+37 days
14 Jun 2017	Published in enforcement report	+7 days

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

Reason for recall

COOK Medical is initiating a voluntary recall of multiple products because the reprocessing instructions do not provide sufficient detailed information for the cleaning, disinfection, and sterilization of these products.

A sterility recall means a product that must be sterile, such as an injection or eye drop, may be contaminated. Using a non-sterile product can cause serious infection.

Product as listed by the FDA

Willscher Vas Reapproximator Set, Surgical Instrument, Supplied sterilized by ethylene oxide gas in peel-open packages. Used to stabilize the vas ends during microscopic vasovasostomy.

Where it was distributed

Worldwide Distribution - US (nationwide) and countries of: Australia, Austria, Belgium, Bahrain, Canada, China, Costa Rica, Finland, France, Germany, Hong Kong, India, Ireland, Italy, Lithuania, Latvia, Malaysia, Netherlands, Romania, Russia, Saudi Arabia, Singapore, Spain, Switzerland, United Arab Emirates, and United Kingdom.

Nationwide

Questions about this recall

Is Willscher Vas Reapproximator Set, Surgical Instrument, Supplied sterilized by ethylene recalled?

Yes. Cook recalled Willscher Vas Reapproximator Set, Surgical Instrument, Supplied sterilized by ethylene on 1 May 2017. The recall is Class II and its status is Terminated. Recall number Z-2310-2017.

Why was it recalled?

Which lots are affected?

CATALOG NUMBER: 092000, GPN: G14500, Dates of Manufacture: January 2012 to March 2016,

Where was it sold?

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 21 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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