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Recall Observatory FDA recall evidence

Device evidence

device-recall:cfres:179628

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 compliance. The design provides airflow to aid in patient comfort and pressure injury prevention.

Official recall number

Z-1457-2020

Evidence summary

Product code
IKY
Recall status
Terminated
Event initiated
January 19, 2020
Root cause
Material/Component Contamination
Source snapshot
5482458777762b1480c71ac49b2913b9c7984bb55aac66a4315d018da7cfed2c
Product
Z-1457-2020

Field note

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