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ENDO GIA ULTRA UNIVERSAL STAPLER (2015-12-03)
- Starting date:
- December 3, 2015
- Posting date:
- January 7, 2016
- 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-56538
Affected Products
A. ENDO GIA ULTRA UNIVERSAL STAPLER
Reason
Covidien is voluntarily recalling specific item codes and production lots of Covidien Endo GIA Ultra Universal stapler handles. This voluntary recall is being conducted following customer reports of instruments failing to fire or partially firing and reports of the instrument articulating lever disengaging during use. If the instrument fails to fire or partially fires, or if the articulating lever desengages, the surgeon may be required to replace the device to continue the procedure.
Affected products
A. ENDO GIA ULTRA UNIVERSAL STAPLER
Lot or serial number
More than 10 numbers, contact manufacturer.
Model or catalog number
- EGIAUSHORT
- EGIAUSTND
- EGIAUXL
Companies
- Manufacturer
-
Covidien LLC
15 Hampshire Street
Mansfield
02048
Massachusetts
UNITED STATES