FDA recall Z-2640-2020

EHOB, Inc. · Class II · device

Product

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.

Reason for recall

QC inspection observed that a portion of the lot may have been contaminated with blood.

Distribution

US Nationwide distribution.

Key facts

Status
Terminated
Initiation date
2020-06-09
Report date
2020-07-29
Termination date
2021-01-25
Voluntary/Mandated
Voluntary: Firm initiated
Location
Indianapolis, IN, United States

Primary source

https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-2640-2020