FDA recall Z-2034-2018

Joerns Healthcare · Class II · device

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 decubitus ulcers (bed sores).

Reason for recall

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.

Distribution

Worldwide Distribution - US Nationwide in the states of UK, Canada, Holland

Key facts

Status
Terminated
Initiation date
2018-05-03
Report date
2018-06-06
Termination date
2023-09-28
Voluntary/Mandated
Voluntary: Firm initiated
Location
Arlington, TX, United States

Primary source

https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-2034-2018