Recall Z-0967-2019— Cook Inc.
Class II · Terminated
Class II FDA medical device recall by Cook Inc., initiated 2018-12-19, terminated 2020-04-28. It names one FDA 510(k) clearance: K152524. 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.. Reason: There is a potential for difficulty in sliding down the retention mechanism on the sets manufactured with a specific extension spring lot..
- Recalling firm
- Cook Inc.
- Classification
- Class II
- Status
- Terminated
- Initiated
- 2018-12-19
- Terminated
- 2020-04-28
- Firm location
- Bloomington, IN, United States
510(k) clearances named in this recall
1 on FDA's recordK-numbers as listed on FDA's Recall Enterprise System record for this event (openFDA device/recall k_numbers). The recall may also cover devices cleared under other submissions not named here.
Product description
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.
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.
Data sourced from openFDA. This site is unofficial and independent of the FDA.