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ProMatt Plus
JOERNS HEALTHCARE, LLC · Model PMPUK-ES · UDI-DI 00810055880904
8
510(k) clearances
1,569
Adverse events (35 deaths)
11
Recalls
158
Facilities
Description
CONTROL UNIT, PROMATT ATA, UK
Recalls
| Date | Firm | Reason |
|---|---|---|
| 2021-05-12 | Stryker Medical Division of Stryker Corporation | Medical devices intended for use in a healthcare facility were distributed to residential customers and may be in use in a home environment. The product s labeling accurately iden |
| 2021-05-12 | Stryker Medical Division of Stryker Corporation | Medical devices intended for use in a healthcare facility were distributed to residential customers and may be in use in a home environment. The product s labeling accurately iden |
| 2021-05-12 | Stryker Medical Division of Stryker Corporation | Medical devices intended for use in a healthcare facility were distributed to residential customers and may be in use in a home environment. The product s labeling accurately iden |
| 2021-04-19 | EHOB, Inc. | Product contamination-a trace amount of dried bodily fluids may expose patients, health care providers to contaminates |
| 2020-08-12 | Stryker Medical Division of Stryker Corporation | Connector between support surface and pump may be out of tolerance resulting in difficulty in removing the CPR connector causing a delay in resuscitation efforts for patients exper |
| 2020-01-19 | EHOB, Inc. | Due to a nonconformance of product contamination (human blood) of Econocare Plus Waffle Overlay products with the (master) lot # 932213A that may affect a subset of the lot- contro |
| 2018-05-03 | Joerns Healthcare | 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 Mattresse |
| 2018-05-03 | Joerns Healthcare | 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 Mattresse |
| 2014-09-01 | Arjo Hospital Equipment AB | The firm received complaints regarding multiple mattresses were showing failures resulting in pressure ulcers. |
| 2011-04-29 | Stryker Medical Division of Stryker Corporation | Affected mattresses may not conform to federal flammability standards. |
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Get your free API keyRead the docsData compiled from public U.S. FDA sources (GUDID, 510(k)/PMA, MAUDE, recalls, establishment registration). Adverse-event reports are unverified and do not establish causation. Informational only — not medical, clinical, or regulatory advice.