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.
Enforcement
- Recall Number
- Z-1457-2020
- Event ID
- 84897
- Classification
- Class II
- Status
- Terminated
- Product Type
- Devices
- Firm
- EHOB, Inc.
- Voluntary / Mandated
- Voluntary: Firm initiated
- Initial Notification
- Letter
- Report Date
- March 18, 2020
- Initiation Date
- January 19, 2020
- Classification Date
- March 9, 2020
- Termination Date
- August 5, 2020
- Address
- 250 N Belmont Ave, Indianapolis, IN, 46222-4265, United States
Description
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.
Due to a nonconformance of product contamination (human blood) of Econocare Plus Waffle Overlay products with the (master) lot # 932213A that may affect a subset of the lot- controlled product (# 932243A). This nonconformance has the potential to expose the end user to materials deemed to be a health risk. Firm is aware of zero instances of contamination in distributed products that have reached consignees.
Master Lot # 932213A, Product Lot Code 932243A
US Nationwide distribution in the state of TX.
U.S. (TX)