Entuit Secure Gastrointestinal Suture Anchor Set (2018-12-18)

Starting date:

December 18, 2018

Posting date:

January 23, 2019

Type of communication:

Medical Device Recall

Subcategory:

Medical Device

Hazard classification:

Type II

Source of recall:

Health Canada

Issue:

Medical Devices

Audience:

General Public, Healthcare Professionals, Hospitals

Identification number:

RA-68838

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  Reason
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  Affected products

Affected products

Entuit Secure Gastrointestinal Suture Anchor Set

Reason

Cook has received complaints for difficulty in sliding down the retention mechanism on Entuit Secure Gastrointestinal Suture Anchor Sets manufactured with a specific extension spring lot. Therefore, Cook is initiating a voluntary recall of the 39 lots of Entuit Secure Gastrointestinal Suture Anchor Sets that were manufactured with the affected extension spring lot.

Affected products