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).
FDA Recall Z-2034-2018 · Posted None
Advertisement
Recalling FirmJoerns Healthcare
Recall StatusTerminated
Product CodeIKY
Date Initiated2018-05-03
Date Terminated2023-09-28
Product Quantity46 units
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.
Firm Action
The firm initiated the recall by letter on 05/04/2018. The letter requested the consignee identify potentially affected mattresses and contact Joerns Healthcare directly to schedule on-site rework of the unit.
Distributors were directed to provide the recall information to their accounts.
Root Cause
Employee error
Distribution Pattern
Worldwide Distribution - US Nationwide in the states of UK, Canada, Holland
Official Source
View FDA Recall →Source: FDA Enforcement Report / Recall database. Always confirm against the official FDA record.
Advertisement