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Health product recall

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

  1. Devon Light Glove - Birthday Kit C-section
  2. Devon Light Gloves
  3. K-1920-COE Mini Kit
  4. 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