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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