Recall Z-2640-2020 ยท FMP Protector, Skin Pressure
EHOB, Inc.
Expansion Control Overlay, Item No. 1004EC - Product Usage: The EHOB WAFFLE Overlay is more than a support surface, assisting in lateral transfers, boosts and turns to protect patients throughout the hospital journey. Through immersion and envelopment, the WAFFLE Overlay is designed to offload the patient and relieve pressure at bony prominences while the unique venting holes allow for air circula
| Date | Jun 9, 2020 |
| Status | Terminated |
| Reason | QC inspection observed that a portion of the lot may have been contaminated with blood. |
| Root cause | Process control |
| Action | On June 9, 2020, the firm notified affected customers through VOLUNTARY MEDICAL DEVICE RECALL letters. Customers were advised that the affected lot of product may have been exposed to dried bodily fluids. Customers were instructed to not remove unused product from their boxes, nor to open sealed plastic bags that the products are contained in. The product is to be returned to the EHOB Indianapolis Distribution enter. Please contact the firm's Customer Service department at customerservice@ehob.com or (317) 972-4600 to arrange free return shipment. For additional information regarding this no |
| Quantity | 173 |
| Distribution | US Nationwide distribution. |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
This recall record lists no 510(k) number.