Health product recall

Covidien Endo GIA Articulating Loading Units (2018-04-26)

Starting date:
April 26, 2018
Posting date:
May 11, 2018
Type of communication:
Medical Device Recall
Subcategory:
Medical Device
Hazard classification:
Type I
Source of recall:
Health Canada
Issue:
Medical Devices
Audience:
General Public, Healthcare Professionals, Hospitals
Identification number:
RA-66730

Affected products

  1. ENDO GIA AUTOSUTURE UNIVERSAL LOADING UNIT ARTICULATING
  2. ENDO GIA CURVED TIP RELOAD W/TRI-STAPLE TECHNOLOGY VASCULAR

Reason

The manufacturer is conducting a voluntary recall due to the potential for a device to be missing the sled component. The sled component is responsible for staple deployment. Without the sled, no staples would be deployed. Use of a product with this issue may result in failure to form a staple line when tissue is divided, leading to bleeding or leakage of luminal contents.

Affected products

A. ENDO GIA AUTOSUTURE UNIVERSAL LOADING UNIT ARTICULATING

Lot or serial number
  • N7D0492KRX
  • N7L0306KX
  • N7L0355KX
  • N7L0397KX
  • N7L0519KX
  • N7L1043KX
  • N7L1159KX
  • N7M0088KX
  • N8A0312KRX
  • N8B0234KX
Model or catalog number
  • 030450
  • 030451
  • 030452
  • 030454
  • 030455
  • 030457
  • 030458
Companies
Manufacturer
Covidien LLC
15 Hampshire Street
Mansfield
02048
Massachusetts
UNITED STATES

B. ENDO GIA CURVED TIP RELOAD W/TRI-STAPLE TECHNOLOGY VASCULAR

Lot or serial number

N7G0796KX

Model or catalog number

EGIA45CTAV

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