Z-0968-2019Class II

Entuit Secure Gastrointestinal Suture Anchor Set, Catalog Number GIAS-SRM-3, Order Number G35570 The Entuit...

Name: Z-0968-2019 Entuit Secure Gastrointestinal Suture Anchor Set, Catalog Number GIAS-SRM-3, Order Number G35570 The Entuit...
Creator: Cook Inc.
Published: 2018-12-19
License: https://open.fda.gov/license/

Cook Incorporated / initiated 2018-12-19 / Terminated / root cause: manufacturing process

FDA source

Cook Inc. began a recall of Entuit Secure Gastrointestinal Suture Anchor Set, Catalog Number GIAS-SRM-3, Order Number G35570 The Entuit Secure Gastrointestinal Suture Anchor Set is... on 2018-12-19. FDA classified it as Class II and gives the reason as "There is a potential for difficulty in sliding down the retention mechanism on the sets manufactured with a specific extension spring lot". As of 2026-09-10, the recall status on record is Terminated, and MDM tags the root cause as manufacturing process.

Recall record

Recall number: Z-0968-2019
Classification: Class II
Status: Terminated
Initiated: 2018-12-19
Posted: 2019-02-28
Terminated: 2020-04-28
Recalling firm: Cook Incorporated
Product: Entuit Secure Gastrointestinal Suture Anchor Set, Catalog Number GIAS-SRM-3, Order Number G35570 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.
Product code: FGE Stents, Drains And Dilators For The Biliary Ducts
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.
Root cause tag: manufacturing process
FDA root cause: Under Investigation by firm
Action: The firm, Cook Medical, sent an "URGENT: MEDICAL DEVICE RECALL" letters dated 12/19/18 to its customers. The letter described the product, problem and actions to be taken. The customers were instruct to do the following: 1. Examine your inventory immediately to determine if you have affected product(s), and quarantine affected product(s). Immediately cease all distribution and use of these products. 2. Return the affected product(s) to Cook Medical with a copy of the Acknowledgement and Receipt Form to receive a product credit. NOTE: Unaffected products that are returned will not be credited. 3. Please complete the Acknowledgement and Receipt Form within 5 business days of receiving this letter. Even if you do not have affected product(s) on hand, you must still complete the Acknowledgement and Receipt Form and return it via fax (812.339.7316) or email ([email protected]). 4. Immediately report adverse events to Cook Medical Customer Relations by phone at 800.457.4500 or 812.339.2235, Monday through Friday between 7:30 am and 5:00 pm (Eastern Time) or by email to [email protected]. If you have any questions or concerns, please contact Cook Medical Customer Relations at 800.457.4500 or 812.339.2235.
Quantity in commerce: 975
Distribution: 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.
Product codes and lots: Lot numbers 8056941,8135292, 8165522, 8228910, 8261265, 8293447, 8331165, 8357394, 8389427,8395982, 8445405, 8471250, 8483543, 8511203, 8556989, 8557006, 8564659, 8622758, 8628912, 8663134

Enforcement reports

One row per recalled product line

FDA enforcement reports joined to recall event Z-0968-2019
Recall number	Class	Status	Voluntary or mandated	Report date	Classified
Z-0967-2019	Class II	Terminated	Voluntary: Firm initiated	2019-03-06	2019-02-28
Z-0968-2019	Class II	Terminated	Voluntary: Firm initiated	2019-03-06	2019-02-28

Product code FGE

K152524Class IIEntuit Secure Gastrointestinal Suture Anchor Set, Entuit Secure Adjustable Gastrointestinal Suture Anchor SetCook Incorporated / cleared 2015-09-30

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 2026-10-07, the FDA export date for this dataset. Page last changed 2026-09-05. View this recall on fda.gov (opens on fda.gov)