Health product recall

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

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

A. Endo Grasp AutoSuture Grasper

Lot or serial number

P8D1335PRX
P8D1336PRX
P8D1605PRX

Model or catalog number

173030

Companies
Manufacturer

Covidien LLC

15 Hampshire Street

Mansfield

02048

Massachusetts

UNITED STATES

B. Endo Clinch II AutoSuture Grasper

Lot or serial number

More than 10 numbers, contact manufacturer.

Model or catalog number

174317

Companies
Manufacturer

Covidien LLC

15 Hampshire Street

Mansfield

02048

Massachusetts

UNITED STATES