U.S. data is current through June 2018. All of the data comes from the U.S. Food and Drug Administration, except for the category Manufacturer Parent Company.
The Parent Company was added by ICIJ.
The parent company information is based on 2017 public records.
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.
조치
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.
Worldwide Distribution - US Nationwide in the states of UK, Canada, Holland
제품 설명
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).