Reported Jun 6, 2018 · Terminated
ProCair Mattress: (a) PROCAIR PLUS 42X80, MATERIAL NUMBER 222-4280 (b) PROCAIR PLUS 36X80, MATERIAL NUMBER 222-3680 (c)…
Joerns Healthcare
Moderate riskThis product could cause temporary or reversible health problems — stop using it.What you should do
Stop using the affected lot and contact the recalling firm for the return or refund process. Check the FDA enforcement report for lot-level detail.
Firm contact: Joerns Healthcare · 2100 Design Rd · Arlington, TX · 76014-4593
Is this the product you have?
- 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 UsageNon powered flotation therapy mattress. The device is intended to treat or prevent decubitus ulcers (bed sores)
- Lot codes and dates
- (a) PROCAIR PLUS 42X80
- MATERIAL NUMBER 222-4280 Serial Numbers1000054866 1000054860 1000051368 1000054859 1000054855 1000054857 (b) PROCAIR PLUS 36X80
- MATERIAL NUMBER 222-3680 Serial Numbers(c) PROCAIR PLUS 84" MATTRESS
1000053319100005331210000528861000053325100005332310000524201000052259100005242610000524251000052432100005289110000524581000052429100005225610000528881000053990100005141810000514191000052457100005225210000514111000055556100005246010000541291000053979100004912910000514121000052424100005245510000541171000053982100005398310000541221000054121
- MATERIAL NUMBER 222-6384 Serial Numbers1000055501 1000049132 1000055498 1000057147 1000055500 1000056219
- Amount recalled
- 46 units
This recall covers 2 products
The agency filed one notice per product. You are reading one of them; the other one is below.
Where it was sold
- Nationwide
Why it was 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.
This product could cause temporary or reversible health problems — stop using it.
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The guide adds the identifying codes laid out for scanning, symptoms to watch for, a timeline, and news coverage of this recall.
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