Device 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.
Z-0967-2019
Product summary
- Firm
- Cook Inc.
- Event
- Event 81979
- Status
- Terminated
- Classification
- Class II
- Quantity
- 797
- Official record key
device-enforcement:Z-0967-2019
Official wording
Reason: There is a potential for difficulty in sliding down the retention mechanism on the sets manufactured with a specific extension spring lot.
Code information: Lot numbers 8144390,8159665, 8173295, 8204594, 8261263,8294836, 8308856, 8331166, 8395981, 8459751, 8471244, 8511162, 8535303, 8541938, 8574041, 8582863, 8597539, 8541938X, 8582863X
Distribution pattern: 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.
Derived failure modes
-
Unknown
There is a potential for difficulty in sliding down the retention mechanism on the sets manufactured with a specific extension spring lot.