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U.S. Department of Health and Human Services

Class 2 Device Recall P.R.O. Matt

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  Class 2 Device Recall P.R.O. Matt see related information
Date Initiated by Firm May 03, 2018
Create Date May 30, 2018
Recall Status1 Terminated 3 on September 28, 2023
Recall Number Z-2033-2018
Recall Event ID 80113
Product Classification Mattress, flotation therapy, non-powered - Product Code IKY
Product P.R.O. Matt:
(a) PROMATT PLUS 36 X 76 MATRESS, NYLON, MATERIAL NUMBER PMP3676NZBA
(b) PROMATT PLUS 84" MATRESS, NYLON, MATERIAL NUMBER PMP3684NZBA
(c) PROMATT PLUS W/SIDEWALLS, 42X80, MATERIAL NUMBER PMS4280NZBA
(d) PROMATT PLUS 36IN MATRESS, MATERIAL NUMBER PMP3680NZBA
(e) PROMATT WITH SIDEWALLS ASSEMBLY, MATERIAL NUMBER PMS3680NZBA
(f) PROMATT PLUS 80IN MATRESS, STRETCH, MATERIAL NUMBER PMP3680SZBA
(g) PROMATT PLUS 42IN MATRESS, MATERIAL NUMBER PMP4280NZBA
(h) PROMATT PLUS 85cm MATRESS, DURATUB, MATERIAL NUMBER PMPE3480SZBADT

Product Usage:
Non powered flotation therapy mattress. The device is intended to treat or prevent decubitus ulcers (bed sores).
Code Information P.R.O. Matt: (a) PROMATT PLUS 36 X 76 MATRESS, NYLON, MATERIAL NUMBER PMP3676NZBA;  Serial Numbers:  1000057154 1000057153  (b) PROMATT PLUS 84" MATRESS, NYLON, MATERIAL NUMBER PMP3684NZBA;  Serial Numbers:  1000051430 1000051425 1000051366 1000051422 1000056411 1000058530 1000056414  (c) PROMATT PLUS W/SIDEWALLS, 42X80, MATERIAL NUMBER PMS4280NZBA;  Serial Numbers:  1000049130 1000054638 1000054639  (d) PROMATT PLUS 36IN MATRESS, MATERIAL NUMBER PMP3680NZBA;  Serial Numbers:  1000057195 1000055122 1000055401 1000057190 1000055328 1000054681 1000057193 1000057171 1000051436 1000055326 1000054386 1000054387 1000054385 1000051441 1000051432 1000051439 1000054936 1000054144 1000054935 1000054390 1000054368 1000051440 1000054932 1000055059 1000055134 1000055070 1000055058 1000055118 1000054872 1000055317 1000055130 1000055074 1000055313 1000055093 1000054906 1000055091 1000055132 1000055068 1000054926 1000054922 1000055065 1000054373 1000055062 1000055329 1000054140 1000054868 1000055319 1000054683 1000051437 1000055111 1000049127 1000054927 1000054380 1000054375 1000052270 1000054383 1000054940 1000053404 1000054143 1000054915 1000054917 1000054379 1000054389 1000054924 1000054941 1000055114 1000054378 1000055316 1000054377 1000055337 1000054933 1000051367 1000054371 1000054388 1000052267 1000054142 1000055332 1000057169 1000057860 1000054907  (e) PROMATT WITH SIDEWALLS ASSEMBLY, MATERIAL NUMBER PMS3680NZBA;  Serial Numbers:  PMS3680NZBA PMS3680NZBA PMS3680NZBA PMS3680NZBA PMS3680NZBA PMS3680NZBA PMS3680NZBA PMS3680NZBA PMS3680NZBA  (f) PROMATT PLUS 80IN MATRESS, STRETCH, MATERIAL NUMBER PMP3680SZBA;  Serial Numbers:  PMP3680SZBA PMP3680SZBA PMP3680SZBA PMP3680SZBA PMP3680SZBA PMP3680SZBA PMP3680SZBA PMP3680SZBA PMP3680SZBA PMP3680SZBA PMP3680SZBA  (g) PROMATT PLUS 42IN MATRESS, MATERIAL NUMBER PMP4280NZBA;  Serial Numbers:  PMP4280NZBA PMP4280NZBA PMP4280NZBA PMP4280NZBA PMP4280NZBA PMP4280NZBA PMP4280NZBA PMP4280NZBA PMP4280NZBA PMP4280NZBA PMP4280NZBA PMP4280NZBA PMP4280NZBA PMP4280NZBA PMP4280NZBA PMP4280NZBA PMP4280NZBA PMP4280NZBA PMP4280NZBA PMP4280NZBA PMP4280NZBA PMP4280NZBA PMP4280NZBA PMP4280NZBA PMP4280NZBA PMP4280NZBA PMP4280NZBA PMP4280NZBA PMP4280NZBA PMP4280NZBA PMP4280NZBA PMP4280NZBA  (h) PROMATT PLUS 85cm MATRESS, DURATUB, MATERIAL NUMBER PMPE3480SZBADT;  Serial Numbers:  PMPE3480SZBADT PMPE3480SZBADT PMPE3480SZBADT   
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 915 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.
3 For details about termination of a recall see Code of Federal Regulations (CFR) Title 21 §7.55.
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