The Recall Desk

FDA (Devices) recall action 80113

Joerns Healthcare recalled 2 products on 2018-06-06

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
2018-06-06
Critical
0
Units
961

Why these products were recalled

Joerns Healthcare has identified a potential issue with some of the P.R.O. Matt and ProCair Mattresses. For the identified serial number range of P.R.O. Matt and ProCair Mattresses incorrect connectors (part #s 206-0401 & 206-0405) were provided by a Joerns supplier without the required internal shutoff valves, these shutoff valves prevent air from escaping from the mattress air cells.

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.

1–2 of 2

  • ModerateFDA (Devices)··2018-06-06

    Joerns Healthcare Recalls P.R.O. Matt and ProCair Mattresses Due to Connector Defect

    Joerns Healthcare is recalling 915 P.R.O. Matt and ProCair Mattresses because incorrect connectors were supplied, lacking internal shutoff valves required to prevent air loss.

    Product
    P.R.O. Matt: (a) PROMATT PLUS 36 X 76 MATRESS, NYLON, MATERIAL NUMBER PMP3676NZBA (b) PROMATT PLUS 84" MATRESS, NYLON, MATERIAL NUMBER PMP3684NZBA (c) PROMATT PLUS W/SIDEWALLS, 42X80, MATERIAL NUMBER PMS4280NZBA (d) PROMATT PLUS 36IN MATRESS, MATERIAL NUMBER PMP3680NZBA (
    Category
    Distribution
    0 states
  • ModerateFDA (Devices)··2018-06-06

    Joerns Healthcare Recalls ProCair Mattresses Due to Missing Air Shutoff Valves

    Joerns Healthcare is recalling specific ProCair and P.R.O. Matt mattresses because they were supplied with connectors lacking required internal shutoff valves, which can cause air to escape from the mattress cells.

    Product
    ProCair Mattress: (a) PROCAIR PLUS 42X80, MATERIAL NUMBER 222-4280 (b) PROCAIR PLUS 36X80, MATERIAL NUMBER 222-3680 (c) PROCAIR PLUS 84" MATTRESS, MATERIAL NUMBER 222-6384 Product Usage: Non powered flotation therapy mattress. The device is intended to treat or prevent dec
    Category
    Distribution
    0 states