The Recall Desk

FDA (Devices) recall action 74581

Invacare Corporation recalled 2 products on 2016-08-17

The FDA (Devices) publishes a recall like this one as 2 separate product records. They share a firm, a date and a cause; this page is all of them in one place, so the scale of the action is visible rather than spread across 2 pages.

Products
2
Announced
2016-08-17
Critical
0
Units
790

Why these products were recalled

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

The agency’s own wording, quoted from the enforcement report.

The unit total adds up the quantities the agency stated for each product. Where a product record gave no figure, or gave a weight rather than a count, it contributes nothing — so the real total is at least this, never less.

States named across these recalls

1–2 of 2

  • ModerateFDA (Devices)··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.

    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…
    Category
    Distribution
    30 states
  • ModerateFDA (Devices)··2016-08-17

    Invacare Pediatric Flowmeter Recalled Due to Upside-Down Rear Scale

    Invacare is recalling 395 Precise Rx Pediatric Flowmeters because the rear gradation scale was printed upside down, which may confuse users.

    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…
    Category
    Distribution
    30 states