Recall Z-2640-2020— EHOB, Inc.
Class II · Terminated
Class II FDA medical device recall by EHOB, Inc., initiated 2020-06-09, terminated 2021-01-25. FDA's recall record names no specific 510(k) clearance for this event. 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: QC inspection observed that a portion of the lot may have been contaminated with blood..
- Recalling firm
- EHOB, Inc.
- Classification
- Class II
- Status
- Terminated
- Initiated
- 2020-06-09
- Terminated
- 2021-01-25
- Firm location
- Indianapolis, IN, United States
Product description
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.
Data sourced from openFDA. This site is unofficial and independent of the FDA.