Z-2640-2020 Class II Terminated
FDA device recall Z-2640-2020 was initiated by EHOB, Inc. on June 9, 2020 and is designated Class II. Reason for recall: QC inspection observed that a portion of the lot may have been contaminated with blood. The recall status is terminated (terminated January 25, 2021). Affected quantity: 173.
Recall Details
- Product Type
- Devices
- Report Date
- July 29, 2020
- Initiation Date
- June 9, 2020
- Termination Date
- January 25, 2021
- Voluntary/Mandated
- Voluntary: Firm initiated
- Product Quantity
- 173
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.
Distribution Pattern
US Nationwide distribution.
Code Information
Lot 93649FA