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Health product recall

Capnostream 20(p) and Battery pack (2016-04-20)

Starting date:
April 20, 2016
Posting date:
April 27, 2016
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-58100

Affected products

  • A. CAPNOSTREAM20P, NELLCOR MODEL
  • B. CAPNOSTREAM BATTERY PACK
  • C.  CAPNOSTREAM20P ROHS COMPLIANT

Reason

This voluntary recall is due to a supplier defect in battery manufacturing that may increase the risk of thermal damage to the battery pack. Medtronic has received seven reports of thermal damage out of 9817 battery packs. Of these seven reports, one involved a fire resulting in smoke inhalation and minor burns.

Affected products

A. CAPNOSTREAM20P, NELLCOR MODEL  

Lot or serial number

More than 10 numbers, contact manufacturer.

Model or catalog number
  • CS08651-01
  • CS08657-01
Companies
Manufacturer
ORIDION MEDICAL 1987 LTD.
7 HAMARPE ST
JERUSALEM
9777407
ISRAEL

B. CAPNOSTREAM BATTERY PACK  

Lot or serial number

More than 10 numbers, contact manufacturer.

Model or catalog number

16400

Companies
Manufacturer
ORIDION MEDICAL 1987 LTD.
7 HAMARPE ST
JERUSALEM
9777407
ISRAEL

C.  CAPNOSTREAM20P ROHS COMPLIANT

Lot or serial number

More than 10 numbers, contact manufacturer.

Model or catalog number
  • CS08651-02
  • CS08657-02
Companies
Manufacturer
ORIDION MEDICAL 1987 LTD.
7 HAMARPE ST
JERUSALEM
9777407
ISRAEL