Devices

Device Recall ProCair Mattress

Model / Serial
(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
Product Classification
General Hospital and Personal Use Devices
Device Class
1
Implanted device?
No
Distribution
Worldwide Distribution - US Nationwide in the states of UK, Canada, Holland
Product Description
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).
Manufacturer
Joerns Healthcare
1 Event
- Recall of Device Recall ProCair Mattress

Manufacturer

Joerns Healthcare

Manufacturer Address
Joerns Healthcare, 2100 Design Rd, Arlington TX 76014-4593
Source
USFDA

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