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INVACARE PRECISE RX PEDIATRIC FLOWMETER (2016-06-30)
- Starting date:
- June 30, 2016
- Posting date:
- July 22, 2016
- Type of communication:
- Medical Device Recall
- Subcategory:
- Medical Device
- Hazard classification:
- Type II
- Source of recall:
- Health Canada
- Issue:
- Medical Devices
- Audience:
- Healthcare Professionals, General Public, Hospitals
- Identification number:
- RA-59460
Affected products
A. INVACARE PRECISE RX PEDIATRIC FLOWMETER
Reason
The rear gradation scale was screen printed upside down on the flowmeter gauge. Proper delivery of oxygen is critical to infants. In the population at greatest risk i.e. pediatric population, health impact specific to high oxygen saturation could result in systemic toxicity, potential lung vascular injury, or over extended period of time could cause blindness.
Affected products
A. INVACARE PRECISE RX PEDIATRIC FLOWMETER
Lot or serial number
16BF017557
16CF030112
16CF030121
16CF032024
16CF040071
16CF040083
16DF040094
Model or catalog number
IRCPF16
IRCPF16AW
Companies
- Manufacturer
-
INVACARE CORPORATION
2101 E. LAKE MARY BLVD.
SANFORD
32773
Florida
UNITED STATES