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Infant Radiant Warmers (2014-11-18)
- Starting date:
- November 18, 2014
- Posting date:
- November 28, 2014
- 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-42685
Recalled Products
Infant Radiant Warmers
Reason
Fisher & Paykel Healthcare is issuing this voluntary recall notice because it has had two confirmed reports of breakage of the nut that secures the heater head in place. Breakage of the nut can cause the heater head to become partially detached and swing towards the bassinet. The heater head did not contact the patient in either case. However, there is the potential that a heater head could contact a patient situated on the bassinet and cause a serious injury.
Affected products
Infant Radiant Warmers
Lot or serial number
071116 to 090810
071208002349 to 090717000930
Model or catalog number
More than 10 numbers, contact manufacturer.
Companies
- Manufacturer
-
Fisher and Paykel Healthcare Ltd.
15 Maurice Paykel Place East Tamaki, P.O. Box 14348 Panmure
Auckland
2013
NEW ZEALAND