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Health product recall

Devon Light Glove Kit (2016-12-23)

Starting date:
December 23, 2016
Posting date:
February 14, 2017
Type of communication:
Medical Device Recall
Subcategory:
Medical Device
Hazard classification:
Type II
Source of recall:
Health Canada
Issue:
Medical Devices
Audience:
General Public, Hospitals, Healthcare Professionals
Identification number:
RA-62172

Affected Products

  1. Devon Birthday Kit C-Section Basic
  2. Devon Light Glove
  3. Devon OR Mini Kit

Reason

Customers have reported that, on rare occasion, the Devon Light Glove may split upon application to the Devon Light Handle Adapter. Some of the reported splits resulted from difficult application of the Light Glove to the Handle Adapter. More recently, clinicians have reported finding splits in the Light Glove following surgery completion, where no difficulty in application of the light glove was encountered or finding splits directly out of the package. A split in the Light Glove causes a breach in the sterile field and can increase the potential for infection. Medtronic has received notice of two patient adverse events (infection) in which the Light Glove splits were found at the conclusion of surgery.

Affected products

A. Devon Birthday Kit C-Section Basic

Lot or serial number

All lots with 630xxx and lower

Model or catalog number

31404851

Companies
Manufacturer
Covidien LLC
15 Hampshire Street
Mansfield
02048
Massachusetts
UNITED STATES

B. Devon Light Glove

Lot or serial number

All lots 630xxx and below

Model or catalog number
  • 31140208
  • 31140216
  • 31140257
Companies
Manufacturer
Covidien LLC
15 Hampshire Street
Mansfield
02048
Massachusetts
UNITED STATES

C. Devon OR Mini Kit

Lot or serial number

All lots 630xxx and below

Model or catalog number
  • 31141552
  • 50000148
Companies
Manufacturer
Covidien LLC
15 Hampshire Street
Mansfield
02048
Massachusetts
UNITED STATES

Date modified: