FDA Medical Device Recalls (openFDA)
Invacare Corporation: 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.
- Recall number
- Z-2365-2016
- Recalling firm
- Invacare Corporation
- 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.
- Status
- Terminated
- Initiated
- 2016-06-21
- Posted
- 2016-08-08
- Terminated
- 2017-02-07
- Reason
- The rear gradation scale was screen printed upside down on the flowmeter gauge.
- 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
- 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.
- Lot, serial or model codes
- Serial numbers for Model IRCPF16AW: 16CF024370, 16CF024373, 16CF024376, 16CF024379, 16CF024382,16CF024368,16CF024369, 16CF024371,16CF024372, 16CF024374,16CF024375, 16CF024377,16CF024378, 16CF024380,16CF024381, 16CF037743.
- 510(k) numbers
- ["K914488"]
- PMA numbers
- not on file
- Product code
- NFB
- Firm FEI
- 3002889431
- Firm city
- Elyria
- Firm state
- OH
- Firm country
- not on file
Where this comes from
- Register
- FDA Medical Device Recalls (openFDA)
- Publisher
- U.S. Food and Drug Administration (openFDA)
- File
- device-recall-0001-of-0001.json.zip
- sha256
- b87518bfe2e8
- Size
- 288210821 bytes
- Published
- 2026-09-28
- Read
- 2026-09-29T08:25:23.626Z
- Source file
- Source file retained · verify
- Refresh due
- 2026-10-06
Unless otherwise noted, the content, data, documentation, code, and related materials on openFDA is public domain and made available with a Creative Commons CC0 1.0 Universal dedication.
Cite as
FDA Medical Device Recalls (openFDA) (U.S. Food and Drug Administration (openFDA)), device-recall-0001-of-0001.json.zip, sha256 b87518bfe2e8, published 2026-09-28