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
- ENDO GIA AUTOSUTURE UNIVERSAL LOADING UNIT ARTICULATING
- 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