Health product recall

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

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

Entuit Secure Gastrointestinal Suture Anchor Set

Lot or serial number
  • 8308856
  • 8395982
  • 8483543
  • 8541938
  • 8564659
  • 8574041
  • 8628912
Model or catalog number

GIAS-SRM-2

Companies
Manufacturer

Cook, Inc.

750 Daniels Way

Bloomington, Indiana

47404

UNITED STATES