Agency classClass IIOur severity:Moderate FDA (Devices)·Z-2364-2016·Announced 2016-08-17

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.

The agency’s classification

FDA (Devices): Class II

Class II is a situation in which use of or exposure to a violative product may cause temporary or medically reversible adverse health consequences, or where the probability of serious adverse health consequences is remote.

This is the agency’s own classification, taken from its notice. The severity score below is our assessment, not the agency’s. How recall classes work

What this means for you

Our assessment, not the agency’s: severity 2/5 (Moderate).

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…
Manufacturer: Invacare Corporation
Category: Medical Device — Oxygen Flowmeter
Hazard: mis-labeling
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

Distributed in 30 states:

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.

See all 2 products in this recall →

Same manufacturer · Invacare Corporation

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Same hazard · mis labeling