Z-2365-2016Class II

Invacare Precise Rx Pediatric Flowmeter Model Number: IRCPF16 AW. Packed one per carton. The lnvacare Precise...

Name: Z-2365-2016 Invacare Precise Rx Pediatric Flowmeter Model Number: IRCPF16 AW. Packed one per carton. The lnvacare Precise...
Creator: Invacare Corporation
Published: 2016-06-21
License: https://open.fda.gov/license/

Invacare GmbH / initiated 2016-06-21 / Terminated / root cause: manufacturing process

FDA source

Invacare Corporation began a recall of Invacare Precise Rx Pediatric Flowmeter Model Number: IRCPF16 AW. Packed one per carton. The lnvacare Precise Rx" Pediatric Flowmeter adapts to lnvacare... on 2016-06-21. FDA classified it as Class II and gives the reason as "The rear gradation scale was screen printed upside down on the flowmeter gauge". As of 2026-09-10, the recall status on record is Terminated, and MDM tags the root cause as manufacturing process.

Recall record

Recall number: Z-2365-2016
Classification: Class II
Status: Terminated
Initiated: 2016-06-21
Posted: 2016-08-08
Terminated: 2017-02-07
Recalling firm: Invacare GmbH
Product: 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.
Product code: NFB Conserver, Oxygen
Reason for recall: The rear gradation scale was screen printed upside down on the flowmeter gauge.
Root cause tag: manufacturing process
FDA root cause: Process control
Action: lnvacare Corporation sent an Urgent Medical Device Recall letter dated June 27, 2016, to all affected consignees with return receipt to notify them of the recall. The letter identified the product, the problem, and the action to be taken by the consignee. Consignees with questions were instructed to call 877-413-6008.
Quantity in commerce: 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.
Product codes and lots: Serial numbers for Model IRCPF16AW: 16CF024370, 16CF024373, 16CF024376, 16CF024379, 16CF024382,16CF024368,16CF024369, 16CF024371,16CF024372, 16CF024374,16CF024375, 16CF024377,16CF024378, 16CF024380,16CF024381, 16CF037743.

Enforcement reports

One row per recalled product line

FDA enforcement reports joined to recall event Z-2365-2016
Recall number	Class	Status	Voluntary or mandated	Report date	Classified
Z-2364-2016	Class II	Terminated	Voluntary: Firm initiated	2016-08-17	2016-08-08
Z-2365-2016	Class II	Terminated	Voluntary: Firm initiated	2016-08-17	2016-08-08

Product code NFB

K914488Class IIModels: Ircrf5, Ircpf16 Flowmeter Accessory KitsInvacare Corp. / cleared 1992-09-15

MDM coverage of this record lists here, newest first.

About this record

Sourced from the FDA device recall database and the FDA enforcement reports, both ingested from openFDA. The recall record supplies the product, the reason and the product code; the enforcement report supplies the classification. The two datasets are exported by FDA on different days, and the date above is the older of the two, so nothing on this page is newer than it says.

MDM adds the root cause tag, derived from FDA’s own root cause text, and the cross-links to the product code, the clearances named on the record and MDM coverage. Where a recall has not been joined to an enforcement report, no classification is shown.

Data as of 2026-09-30, the FDA export date for this dataset. Page last changed 2026-09-05. View this recall on fda.gov (opens on fda.gov)