Recall record at a glance
| Official record | Z-2033-2018 |
|---|---|
| Category | Medical Device Recalls |
| Classification | Class II |
| FDA record status | Terminated |
| Recalling firm | Joerns Healthcare |
| Report date | Jun 6, 2018 |
| Recall initiation date | May 3, 2018 |
| Quantity | 915 units |
| Location | Arlington, TX, United States |
Official product description
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).
Why the product 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.
Distribution information
Worldwide Distribution - US Nationwide in the states of UK, Canada, Holland
How to read the classification
FDA Class II indicates a situation in which use of or exposure to the product may cause temporary or medically reversible adverse health consequences, or where the probability of serious consequences is remote. The classification shown here comes from the FDA record.
Additional record details
Recall type: Voluntary: Firm initiated. Initial notification: Letter.
What to do next
If you believe you have the recalled product, use the recall number and firm information above to confirm the official notice and follow the instructions issued by the FDA, recalling firm, retailer or product manufacturer. For drugs and medical devices, decisions about treatment or medical care should be discussed with a qualified health professional.
About this record
Recall Lookup USA preserves the most complete source information successfully retrieved. We do not create missing facts or infer affected lots or VINs. The official record may still change, so use the identifier above when verifying current instructions.
FDA source limitation: openFDA enforcement reports are a reference dataset, not a live public-alert or recall-lifecycle service. FDA notes that enforcement-report status may not be updated after classification. Confirm current actions with the FDA, recalling firm or appropriate healthcare professional when relevant.