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

LapSac Introducer Set, Extraction recalled by Cook

Cook is recalling LapSac Introducer Set, Extraction, Supplied sterilized by ethylene oxide gas in peel-open, 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 and GPN: 054300 & G15771 Dates of Manufacture: January 2012 to August 2015

Quantity recalled327 lots, 335 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-2315-2017
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: Heart & Vascular Devices

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

LapSac Introducer Set, Bag, Extraction, Supplied sterilized by ethylene oxide gas in peel-open packages. Used to aid in the introduction of a LapSac during endoscopic surgical procedures.

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 LapSac Introducer Set, Extraction, Supplied sterilized by ethylene oxide gas in peel-open recalled?

Yes. Cook recalled LapSac Introducer Set, Extraction, Supplied sterilized by ethylene oxide gas in peel-open on 1 May 2017. The recall is Class II and its status is Terminated. Recall number Z-2315-2017.

Why was it recalled?

Which lots are affected?

CATALOG NUMBER and GPN: 054300 & G15771 Dates of Manufacture: January 2012 to August 2015

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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