medical Class II Updated 2019-03-06

Cook Inc. recalls Entuit Secure Gastrointestinal Suture Anchor Set, Catalog Nu

Recalled Product

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.


Hazard / Issue

There is a potential for difficulty in sliding down the retention mechanism on the sets manufactured with a specific extension spring lot.

Issued by

FDA

Distribution: Nationwide (United States)
Lot/Code Info: Lot numbers 8056941,8135292, 8165522, 8228910, 8261265, 8293447, 8331165, 8357394, 8389427,8395982, 8445405, 8471250, 8483543, 8511203, 8556989, 8557006, 8564659, 8622758, 8628912, 8663134
View official government recall

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