PlainRecalls
FDA Devices Moderate Class II Terminated

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.

Reported: August 17, 2016 Initiated: June 21, 2016 #Z-2365-2016

Product Description

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.

Reason for Recall

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

Details

Recalling Firm
Invacare Corporation
Units Affected
395 units
Distribution
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.
Location
Elyria, OH

Frequently Asked Questions

What product was recalled?
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.. Recalled by Invacare Corporation. Units affected: 395 units.
Why was this product recalled?
The rear gradation scale was screen printed upside down on the flowmeter gauge.
Which agency issued this recall?
This recall was issued by the FDA Devices on August 17, 2016. Severity: Moderate. Recall number: Z-2365-2016.