Recall Z-1457-2020 ยท IKY Mattress, Flotation Therapy, Non-Powered
EHOB, Inc.
Econocare Plus Overlay Item: 1025EC. Intended to aid in the prevention and treatment of pressure injuries and general comfort - Product Usage: The EHOB WAFFLE Overlay intended use is as first line of defense for pressure injury prevention. The design provides the caregiver a point-of-care solution with the versatility of patient handling and transferring, which encourages ease of use and complia
| Date | Jan 19, 2020 |
| Status | Terminated |
| Reason | 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- controlled product (# 932243A). This nonconformance has the potential to expose the end user to materials deemed to be a health risk. Firm is aware of zero instances of contamination in distributed products that have reached consignees. |
| Root cause | Material/Component Contamination |
| Action | EHOB, Inc. issued a "Voluntary Medical Device Recall" letter dated January 19, 2020 via email. Letter provides identification of the issue, health risk and action to take. Distributor was advised that the products have the potential to expose patients, health care providers, or other persons when handling them unpackaged, to dried bodily fluids and told products should not be removed from their boxes as they are packaged in an arrangement to eliminate exposure via individually sealed plastic bag containers inside the corrugate box. Do not open the sealed plastic bags that the products are con |
| Quantity | U.S. (TX) |
| Distribution | US Nationwide distribution in the state of TX. |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
This recall record lists no 510(k) number.