FDA-Device2020-07-29Class II
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 circulation to keep patients cool, dry and comfortable.
EHOB, Inc.
Hazard
QC inspection observed that a portion of the lot may have been contaminated with blood.
Sold states
US Nationwide distribution.
Affected count
173
Manufactured in
250 N Belmont Ave, N/A, Indianapolis, IN, United States
Products
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 circulation to keep patients cool, dry and comfortable.
Official notice
https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-2640-2020Don't want to check this manually?
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