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U.S. Department of Health and Human Services

Class 2 Device Recall Entuit Secure Gastrointestinal Suture Anchor Set

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  Class 2 Device Recall Entuit Secure Gastrointestinal Suture Anchor Set see related information
Date Initiated by Firm December 19, 2018
Create Date February 28, 2019
Recall Status1 Terminated 3 on April 28, 2020
Recall Number Z-0967-2019
Recall Event ID 81979
510(K)Number K152524  
Product Classification Stents, drains and dilators for the biliary ducts - Product Code FGE
Product 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.
Code Information Lot numbers 8144390,8159665, 8173295, 8204594, 8261263,8294836, 8308856, 8331166, 8395981, 8459751, 8471244, 8511162, 8535303, 8541938, 8574041, 8582863, 8597539, 8541938X, 8582863X
Recalling Firm/
Manufacturer		 Cook Inc.
750 N Daniels Way
Bloomington IN 47404-9120
For Additional Information Contact
812-339-2235
Manufacturer 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.
FDA Determined
Cause 2		 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 (FieldActionsNA@CookMedical.com). 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 CustomerRelationsNA@CookMedical.com. If you have any questions or concerns, please contact Cook Medical Customer Relations at 800.457.4500 or 812.339.2235.
Quantity in Commerce 797
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.
Total Product Life Cycle TPLC Device Report
1 A record in this database is created when a firm initiates a correction or removal action. The record is updated if the FDA identifies a violation and classifies the action as a recall, and it is updated for a final time when the recall is terminated. Learn more about medical device recalls.
2 Per FDA policy, recall cause determinations are subject to modification up to the point of termination of the recall.
3 For details about termination of a recall see Code of Federal Regulations (CFR) Title 21 §7.55.
510(K) Database 510(K)s with Product Code = FGE and Original Applicant = COOK INCORPORATED
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