Recall Z-0967-2019 ยท FGE Stents, Drains And Dilators For The Biliary Ducts
Cook Inc.
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.
| Date | Dec 19, 2018 |
| Status | Terminated |
| Reason | There is a potential for difficulty in sliding down the retention mechanism on the sets manufactured with a specific extension spring lot. |
| 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. |
| Quantity | 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. |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
| K152524 | Entuit Secure Gastrointestinal Suture Anchor Set, Entuit Secure Adjustable Gastrointestinal Suture Anchor Set Cook Incorporated, Sep 30, 2015 |