Health product recall

Endo GIA: Ultra Articulating Sulu w/Tri-Staple Technology Med/Thick and Med/Thick Dissect, Reload w/Tri-Staple Technology Med/Thick, Curved Tip Reload w/Tri-Staple Technology Medium/Thick (2019-05-16)

Starting date:
May 16, 2019
Posting date:
June 7, 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-70125

Last updated: 2019-06-07

Affected Products

  1. Endo GIA Ultra Articulating Sulu w/Tri-Staple Technology Med/Thick
  2. Endo GIA Ultra Articulating Sulu w/Tri-Staple Technology Med/Thick Dissect
  3. Endo GIA Reload w/Tri-Staple Technology Med/Thick
  4. Endo GIA Curved Tip Reload w/Tri-Staple Technology Medium/Thick

Reason

This voluntary recall is being conducted due to the potential for a device to be missing one of two pin components that maintain alignment of the device jaws. The affected devices were distributed between april 2014 and april 2019. Use of a product without a pin may result in incomplete staple formation, potentially leading to bleeding, anastomotic leak, peritonitis, or pneumothorax which can result in the potential for infection and/or sepsis. This potential issue was identified during in-process quality testing at the manufacturing facility. Manufacturing process improvements have been implemented to address this issue.

Affected products

A. Endo GIA Ultra Articulating Sulu w/Tri-Staple Technology Med/Thick

Lot or serial number

All lots.

Model or catalog number

EGIA30AMT
EGIA45AMT
EGIA60AMT

Companies
Manufacturer
Covidien LLC
15 Hampshire Street
Mansfield
02048
Massachusetts
UNITED STATES

B. Endo GIA Ultra Articulating Sulu w/Tri-Staple Technology Med/Thick Dissect

Lot or serial number

All lots.

Model or catalog number

EGIA60CTAMT

Companies
Manufacturer
Covidien LLC
15 Hampshire Street
Mansfield
02048
Massachusetts
UNITED STATES

C. Endo GIA Reload w/Tri-Staple Technology Med/Thick

Lot or serial number

All lots.

Model or catalog number

EGIA30AMT
EGIA45AMT
EGIA60AMT

Companies
Manufacturer
Covidien LLC
15 Hampshire Street
Mansfield
02048
Massachusetts
UNITED STATES

D. Endo GIA Curved Tip Reload w/Tri-Staple Technology Medium/Thick

Lot or serial number

All lots.

Model or catalog number

EGIA45CTAMT
EGIA60CTAMT

Companies
Manufacturer
Covidien LLC
15 Hampshire Street
Mansfield
02048
Massachusetts
UNITED STATES

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