FDAJune 9, 2020device
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 th...
Official recall recorded by the U.S. Food & Drug Administration.
The hazard
QC inspection observed that a portion of the lot may have been contaminated with blood.
What to do
FDA enforcement status: Terminated
Brands named
ehob
Recall history
Other federal recalls tied to the same brand — a factual pattern, straight from the source data.
- FDAEconocare 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: 1025ECP2021-04-19
- FDAEconocare 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 solutio...2020-01-19
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