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Devon Light Gloves and K-1920 Kits (2015-04-20)
- Starting date:
- April 20, 2015
- Posting date:
- May 26, 2015
- 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-53393
Recalled Products
- Devon Light Glove - Birthday Kit C-section
- Devon Light Gloves
- K-1920-COE Mini Kit
- K-1920-S-Surgical Kit
Reason
Covidien is voluntary recalling specific lots of the Devon light gloves and specific sterile kits. This recall is being conducted due to the risk that Devon light gloves of these lots could contain splits or holes that could result in an unintentional transfer of microorganisms by the clinician from the light handle into the patient wound.
Affected products
A. Devon Light Glove - Birthday Kit C-section
Lot or serial number
Lot # 508xxxx or lower
Model or catalog number
- 31404851
Companies
- Manufacturer
-
Covidien LLC
15 Hampshire Street
Mansfield
Massachusetts
UNITED STATES
B. Devon Light Gloves
Lot or serial number
Lot # 508xxxx or lower
Model or catalog number
- 31140208
- 31140216
- 31140257
Companies
- Manufacturer
-
Covidien LLC
15 Hampshire Street
Mansfield
Massachusetts
UNITED STATES
C. K-1920-COE Mini Kit
Lot or serial number
Lot # 508xxxx or lower
Model or catalog number
- 50000148
Companies
- Manufacturer
-
Covidien LLC
15 Hampshire Street
Mansfield
Massachusetts
UNITED STATES
D. K-1920-S-Surgical Kit
Lot or serial number
Lot # 508xxxx or lower
Model or catalog number
- 31141552
Companies
- Manufacturer
-
Covidien LLC
15 Hampshire Street
Mansfield
Massachusetts
UNITED STATES