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U.S. Department of Health and Human Services

Class 2 Device Recall ProCair Mattress

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  Class 2 Device Recall ProCair Mattress see related information
Date Initiated by Firm May 03, 2018
Create Date May 30, 2018
Recall Status1 Completed
Recall Number Z-2034-2018
Recall Event ID 80113
Product Classification Mattress, flotation therapy, non-powered - Product Code IKY
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).



Code Information (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 
Recalling Firm/
Manufacturer
Joerns Healthcare
2100 Design Rd
Arlington TX 76014-4593
For Additional Information Contact
800-826-0270 Ext. 5402
Manufacturer 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.
FDA Determined
Cause 2
Employee error
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.
Quantity in Commerce 46 units
Distribution Worldwide Distribution - US Nationwide in the states of UK, Canada, Holland
Total Product Life Cycle TPLC Device Report

1 A record in this database is created when a firm initiates a correction or removal action. The record is updated if the FDA identifies a violation and classifies the action as a recall, and it is updated for a final time when the recall is terminated. Learn more about medical device recalls.
2 Per FDA policy, recall cause determinations are subject to modification up to the point of termination of the recall.
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