CLASS II Device recall · Reported 17 Aug 2016 · FDA Enforcement Report

Precise Rx Pediatric Flowmeter recalled by Invacare

Invacare is recalling Precise Rx Pediatric Flowmeter, distributed in 30 states. The recall was initiated on 21 Jun 2016 and the FDA has classified it as Class II.

Check your package

Lot, batch or date codesSerial numbers for Model IRCPF16AW: 16CF024370, 16CF024373, 16CF024376, 16CF024379, 16CF024382,16CF024368,16CF024369, 16CF024371,16CF024372, 16CF024374,16CF024375, 16CF024377,16CF024378, 16CF024380,16CF024381, 16CF037743.

Quantity recalled395 units

Stop using the device if the notice says to, and contact the manufacturer or your healthcare provider for the correction or replacement.

Recall details

Recall number: Z-2365-2016
FDA event ID: 74581
Recalling firm: Invacare, Elyria, OH
Classification: Class II
Status: Terminated
Recall initiated: 21 Jun 2016
FDA classified: 8 Aug 2016
Reported: 17 Aug 2016
Type: Voluntary: Firm initiated
Customers notified by: Letter
Reason category: Other Reasons
Device type: Patient Monitors

Timeline

21 Jun 2016	Recall initiated by company
8 Aug 2016	Classified by FDA	+48 days
17 Aug 2016	Published in enforcement report	+9 days

Companies usually start a recall weeks before the FDA classifies and publishes it; the gap above is that lag.

Reason for recall

The rear gradation scale was screen printed upside down on the flowmeter gauge.

Product as listed by the FDA

Invacare Precise Rx Pediatric Flowmeter Model Number: IRCPF16 AW. 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 source for monitoring oxygen flow. The rear scale is an aide for monitoring oxygen flow.

Where it was distributed

Worldwide Distribution - US to CA, CO, CT, FL, GA, IA, ID, IL,IN,KS,KY,LA,MA,MD,MI,MS,MT,NC,NE,NJ,NM,NY,OH,PA,SC, TN,TX,UT,VA,WA and Internationally to Canada, Germany and New Zealand.

California Colorado Connecticut Florida Georgia Iowa Idaho Illinois Indiana Kansas Kentucky Louisiana Massachusetts Maryland Michigan Mississippi Montana North Carolina Nebraska New Jersey

Questions about this recall

Why was it recalled?

The rear gradation scale was screen printed upside down on the flowmeter gauge.

Which lots are affected?

Serial numbers for Model IRCPF16AW: 16CF024370, 16CF024373, 16CF024376, 16CF024379, 16CF024382,16CF024368,16CF024369, 16CF024371,16CF024372, 16CF024374,16CF024375, 16CF024377,16CF024378, 16CF024380,16CF024381, 16CF037743.

Where was it sold?

Worldwide Distribution - US to CA, CO, CT, FL, GA, IA, ID, IL,IN,KS,KY,LA,MA,MD,MI,MS,MT,NC,NE,NJ,NM,NY,OH,PA,SC, TN,TX,UT,VA,WA and Internationally to Canada, Germany and New Zealand.

What should I do if I have it?

Stop using the device if the notice says to, and contact the manufacturer or your healthcare provider for the correction or replacement.

What does Class II mean?

Class II means the product may cause temporary or medically reversible health problems, or the probability of serious harm is remote.

Read the official FDA notice · Source record retrieved 26 Sep 2026. The FDA describes openFDA data as unvalidated; the official notice takes precedence. This page reports the record and gives no medical advice.

Other products in this recall event

1 other product · FDA event 74581

Reported	Class	Recall	Company	Reason	Where
17 Aug 2016	CLASS II	lnvacare Precise Rx Pediatric Flowmeter recalled by Invacare	Invacare	Other	30 states

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