Invacare Pediatric Flowmeter Recalled for Upside-Down Rear Scale Printing
Invacare is recalling 395 Precise Rx Pediatric Flowmeters because the rear gradation scale was printed upside down, which may cause confusion during oxygen flow monitoring.
What this means for you
Minor labeling or packaging issue, or a voluntary precautionary recall. Risk of harm is low but real — follow the manufacturer's instructions.
Our severity reasoning: The recall is classified as FDA Class II, and the hazard involves a labeling/printing error on a secondary scale that could lead to incorrect monitoring, fitting the criteria for moderate severity without reported injuries.
Plain-English summary
Invacare Corporation is recalling 395 units of the lnvacare Precise Rx Pediatric Flowmeter, Model Number IRCPF16. The recall was initiated because the rear gradation scale on the flowmeter gauge was screen printed upside down. The front scale is the primary source for monitoring oxygen flow, while the rear scale is intended as an aide for monitoring.
The affected units were distributed worldwide, including to specific states in the United States and internationally to Canada, Germany, and New Zealand. The recall covers specific serial numbers listed in the official FDA record Z-2364-2016.
Consumers and healthcare providers should check the serial numbers of their flowmeters against the list provided by the FDA. If a unit is affected, it should be returned to Invacare Corporation for replacement or repair. The upside-down printing on the rear scale may lead to misinterpretation of the oxygen flow rate if users rely on that secondary scale.
The recalled product
- Product
- lnvacare Precise Rx Pediatric Flowmeter Model Number: IRCPF16. Packed one per carton. The lnvacare Precise Rx Pediatric Flowmeter adapts to lnvacare Concentrators for low-flow usage.The gauge has a scale printed on the front side and the back side. The front scale is the primary
- Manufacturer
- Invacare Corporation
- Hazard
- Affected units
- 395
Is your product affected?
Check your packaging against the codes below. If any of them match, the product is part of this recall.
Lot numbers (20)
- Serial numbers for Model IRCPF16: 16BF023724
- 16BF023729
- 16BF023734
- 16BF023739
- 16BF023744
- 16BF023720
- 16BF023725
- 16BF023730
- 16BF023735
- 16BF023740
- 16BF023745
- 16BF023721
- 16BF023726
- 16BF023731
- 16BF023736
- 16BF023741
- 16BF023746
- 16BF023722
- 16BF023727
- 16BF023732
Distribution
Part of a larger recall action
This product is one of 2 recalled by Invacare Corporation under a single FDA (Devices) recall action. The agency files each product separately, so the size of the action is not visible from this page alone.
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