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Endo GIA Autosuture Universal (2015-01-29)
- Starting date:
- January 29, 2015
- Posting date:
- February 16, 2015
- Type of communication:
- Medical Device Recall
- Subcategory:
- Medical Device
- Hazard classification:
- Type III
- Source of recall:
- Health Canada
- Issue:
- Medical Devices
- Audience:
- General Public, Healthcare Professionals, Hospitals
- Identification number:
- RA-43733
Recalled Products
A) Endo GIA Autosuture Universal
Reason
The lots number beginning with the prefix "H", contain modifications to the device that did not receive required country-specific regulatory authorization for distribution. The modifications to these devices do not pose any risk to patients or clinicians.
Affected products
A) Endo GIA Autosuture Universal
Lot or serial number
H3F
H3J
H3K
H3L
H3M
H4A
H4B
H4C
H4D
H4E
H4F
Model or catalog number
030455
030456
030458
030459
Companies
- Manufacturer
-
Covidien LLC
15 Hampshire Street
Mansfield
02048
Massachusetts
UNITED STATES