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Echelon 60mm Black Reload
- Starting date:
- May 22, 2013
- Posting date:
- June 18, 2013
- 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-34231
Recalled products
- Echelon 60mm Black Reload
Reason
Ethicon is initiating a worldwide recall for Echelon 60mm Endoscopic Linear Cutter Reloads Black (ECR60T) due to the potential for incomplete staple line formation from reload damage during the firing sequence. This may result in insufficient tissue apposition that could require surgical intervention to help achieve and maintain anastomotic integrity.
Affected products
A. Echelon 60mm Black Reload
Lot or serial number
With expiry dates: 2013/05 to 2014/03
Model or catalog number
- ECR60T
Companies
- Manufacturer
-
Ethicon Endo-Surgery, LLC.
475 Calle C,
Guaynabo, Puerto Rico
00969
UNITED STATES