Endo Grasph, Endo Clinch II AutoSuture Grasper (2019-03-10)

Starting date:

March 10, 2019

Posting date:

March 28, 2019

Type of communication:

Medical Device Recall

Subcategory:

Medical Device

Hazard classification:

Type II

Source of recall:

Health Canada

Identification number:

RA-69430

• 
  Reason
• 
  Affected products

Affected Products

A. Endo Grasp AutoSuture Grasper

B. Endo Clinch II AutoSuture Grasper

Reason

Medtronic is issuing a voluntary recall following a review of a production records which indicate that the sterilization method used for these lots were not consistent with the labeling and the approved sterilization method. These products are labeled as sterilized with gamma radiation and in some cases, the devices were subjected to re-sterilization with ethylene oxide or a repeat gamma sterilization cycle. While re-sterilization with ethylene oxide does not impact device performance, it is not consistent with the product labeling.

Affected products