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.
Reported: March 6, 2019 Initiated: December 19, 2018 #Z-0968-2019
Product Description
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.
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.
Details
- Recalling Firm
- Cook Inc.
- Units Affected
- 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.
- Location
- Bloomington, IN
Frequently Asked Questions
What product was recalled? ▼
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.. Recalled by Cook Inc.. Units affected: 975.
Why was this product recalled? ▼
There is a potential for difficulty in sliding down the retention mechanism on the sets manufactured with a specific extension spring lot.
Which agency issued this recall? ▼
This recall was issued by the FDA Devices on March 6, 2019. Severity: Moderate. Recall number: Z-0968-2019.
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