CLASS II Device recall · Reported 6 Mar 2019 · FDA Enforcement Report

Entuit Secure Gastrointestinal Suture Anchor Set recalled by Cook

Cook is recalling Entuit Secure Gastrointestinal Suture Anchor Set, distributed nationwide in the US. The recall was initiated on 19 Dec 2018 and the FDA has classified it as Class II.

Check your package

Lot, batch or date codesLot numbers 8144390,8159665, 8173295, 8204594, 8261263,8294836, 8308856, 8331166, 8395981, 8459751, 8471244, 8511162, 8535303, 8541938, 8574041, 8582863, 8597539, 8541938X, 8582863X

Quantity recalled797

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-0967-2019
FDA event ID: 81979
Recalling firm: Cook, Bloomington, IN
Classification: Class II
Status: Terminated
Recall initiated: 19 Dec 2018
FDA classified: 28 Feb 2019
Reported: 6 Mar 2019
Type: Voluntary: Firm initiated
Customers notified by: Letter
Reason category: Other Reasons
Device type: Heart & Vascular Devices

Timeline

19 Dec 2018	Recall initiated by company
28 Feb 2019	Classified by FDA	+71 days
6 Mar 2019	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

There is a potential for difficulty in sliding down the retention mechanism on the sets manufactured with a specific extension spring lot.

Product as listed by the FDA

Entuit Secure Gastrointestinal Suture Anchor Set, Catalog Number GIAS-SRM-2, Order Number G35569 The Entuit Secure Gastrointestinal Suture Anchor Set is intended for anchoring the anterior wall of the stomach to the abdominal wall prior to the introduction of interventional catheters.

Where it was distributed

Worldwide Distribution: US (nationwide) to of states: AL, AZ, CA, GA, HI, IL, IN, KY, LA, MI, MN, MO, NC, NJ, NY, OH, PA, RI, TN, TX, and UT; and countries of: Austria, Belgium, Canada, Denmark, France, Germany, Great Britain, Hungary, Iceland, Italy, Netherlands, Norway, Spain, and Switzerland.

Nationwide Alabama Arizona California Georgia Hawaii Illinois Indiana Kentucky Louisiana Michigan Minnesota Missouri North Carolina New Jersey New York Ohio Pennsylvania Rhode Island Tennessee Texas

Questions about this recall

Why was it recalled?

There is a potential for difficulty in sliding down the retention mechanism on the sets manufactured with a specific extension spring lot.

Which lots are affected?

Lot numbers 8144390,8159665, 8173295, 8204594, 8261263,8294836, 8308856, 8331166, 8395981, 8459751, 8471244, 8511162, 8535303, 8541938, 8574041, 8582863, 8597539, 8541938X, 8582863X

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 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.

Other products in this recall event

1 other product · FDA event 81979

This product is part of a recall event; the main page for the event is Entuit Secure Gastrointestinal Suture Anchor Set recalled by Cook.

Reported	Class	Recall	Company	Reason	Where
6 Mar 2019	CLASS II	Entuit Secure Gastrointestinal Suture Anchor Set recalled by Cook	Cook	Other	Nationwide

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