CLASS II Device recall · Reported 6 Jun 2018 · FDA Enforcement Report
ProCair Mattress: (a) Procair Plus recalled by Joerns Healthcare
Joerns Healthcare is recalling ProCair Mattress: (a) Procair Plus , Material Number 222-4280 (b) Procair Plus , Material, distributed nationwide in the US. The recall was initiated on 3 May 2018 and the FDA has classified it as Class II.
Check your package
Stop using the device if the notice says to, and contact the manufacturer or your healthcare provider for the correction or replacement.
Recall details
- Recall number
- Z-2034-2018
- FDA event ID
- 80113
- Recalling firm
- Joerns Healthcare, Arlington, TX
- Classification
- Class II
- Status
- Terminated
- Recall initiated
- 3 May 2018
- FDA classified
- 30 May 2018
- Reported
- 6 Jun 2018
- Type
- Voluntary: Firm initiated
- Customers notified by
- Letter
- Reason category
- Other Reasons
- Device type
- Other Medical Devices
Timeline
| 3 May 2018 | Recall initiated by company | |
| 30 May 2018 | Classified by FDA | +27 days |
| 6 Jun 2018 | Published in enforcement report | +7 days |
Companies usually start a recall weeks before the FDA classifies and publishes it; the gap above is that lag.
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.
Product as listed by the FDA
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).
Where it was distributed
Worldwide Distribution - US Nationwide in the states of UK, Canada, Holland
Questions about this recall
Is ProCair Mattress: (a) Procair Plus , Material Number 222-4280 (b) Procair Plus , Material recalled?
Yes. Joerns Healthcare recalled ProCair Mattress: (a) Procair Plus , Material Number 222-4280 (b) Procair Plus , Material on 3 May 2018. The recall is Class II and its status is Terminated. Recall number Z-2034-2018.
Why was it 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.
Which lots are affected?
(a) PROCAIR PLUS 42X80, MATERIAL NUMBER 222-4280 Serial Numbers: 1000054866 1000054860 1000051368 1000054859 1000054855 1000054857 (b) PROCAIR PLUS 36X80, MATERIAL NUMBER 222-3680 Serial Numbers: 1000053319 1000053312 1000052886 1000053325 1000053323 1000052420 1000052259 1000052426 1000052425 1000052432 1000052891 1000052458 1000052429 1000052256 1000052888 1000053990 1000051418 1000051419 1000052457 1000052252 1000051411 1000055556 1000052460 1000054129 1000053979 1000049129 1000051412 1000052424 1000052455 1000054117 1000053982 1000053983 1000054122 1000054121 (c) PROCAIR PLUS 84" MATTRESS, MATERIAL NUMBER 222-6384 Serial Numbers: 1000055501 1000049132 1000055498 1000057147 1000055500 1000056219
Where was it sold?
Worldwide Distribution - US Nationwide in the states of UK, Canada, Holland
What should I do if I have it?
Stop using the device if the notice says to, and contact the manufacturer or your healthcare provider for the correction or replacement.
What does Class II mean?
Class II means the product may cause temporary or medically reversible health problems, or the probability of serious harm is remote.
Read the official FDA notice · Source record retrieved 21 Sep 2026. The FDA describes openFDA data as unvalidated; the official notice takes precedence. This page reports the record and gives no medical advice.
More recalls from Joerns Healthcare
All 3| Reported | Class | Recall | Company | Reason | Where |
|---|---|---|---|---|---|
| Device | CLASS II | P.R.O. Matt: (a) Promatt Plus Matress, Nylon recalled | Joerns Healthcare | Other | Nationwide |
| Device | CLASS II | Joerns EasyCare Bed recalled by Joerns Healthcare | Joerns Healthcare | Device Malfunction | Nationwide |
Other Other Medical Devices recalls
All 13,778| Reported | Class | Recall | Company | Reason | Where |
|---|---|---|---|---|---|
| Device | CLASS II | Citric Complete Dry Citric Acid Concentrate recalled | Nipro Renal Soultions USA | Other | Nationwide |
| Device | CLASS I | Kit: Epidural/Pain TQC 20/Cs recalled by Medical Action Industries | Medical Action Industries Inc. 306 | Sterility | 6 states |
| Device | CLASS II | Halyard IV Start Kit Non-Sterile recalled by Avid Medical | Avid Medical | Sterility | Nationwide |
| Device | CLASS I | Kit: Single Shot Epidural 20/Cs recalled by Medical Action Industries | Medical Action Industries Inc. 306 | Sterility | 6 states |
| Device | CLASS II | AMS Convenience Kit: Dsaek Pack - RX recalled | Windstone Medical Packaging | Device Malfunction | Nationwide |