Recall Z-1950-2021 ยท IKY Mattress, Flotation Therapy, Non-Powered
EHOB, Inc.
Econocare Plus Waffle Overlay- Intended for use as a medical device to aid in the prevention and treatment of pressure injuries or bed sores and general comfort. Product Code: 1025ECP
| Date | Apr 19, 2021 |
| Status | Open, Classified |
| Reason | Product contamination-a trace amount of dried bodily fluids may expose patients, health care providers to contaminates |
| Root cause | Process control |
| Action | EHOB issued recall notification Urgent Medical Device Recall letter 0n 4/19/21 via electronically tracked signature documents. The letter states reason for recall, health risk and action to take: Products should not be removed from their box 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 contained in. This recall notice is temporary, is limited to the identified lot of this product, and does not cause a shortage of availability. Additionally, all othe |
| Quantity | 70 units |
| Distribution | US Nationwide distribution in the states of AZ, IN, ME, NE, OH, SD. |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
This recall record lists no 510(k) number.