Z-0728-2017 Class II Terminated
FDA device recall Z-0728-2017 was initiated by ErgoSafe Products, LLC (DBA) Prism Medical on Aug 30, 2016 and is designated Class II. Reason for recall: The black plastic puck on the carry bar is breaking resulting in potential for patient harm. The recall status is terminated (terminated Jul 18, 2018). Affected quantity: not greater than 17,964 units.
Recall Details
- Product Type
- Devices
- Report Date
- Dec 21, 2016
- Initiation Date
- Aug 30, 2016
- Termination Date
- Jul 18, 2018
- Voluntary/Mandated
- Voluntary: Firm initiated
- Product Quantity
- not greater than 17,964 units
Product Description
Carry bar which is an accessory to a lift used for patients in hospitals and other facilities. Recall impacts the following model numbers: 360741, 360750, 360751, 360755, 360755 Rev B, 360756, and 360757.
Reason for Recall
The black plastic puck on the carry bar is breaking resulting in potential for patient harm.
Distribution Pattern
Distributed US nationwide and to Canada, Japan, Australia, Thailand, Great Britain, and South Korea
Code Information
There are no lot numbers, serial numbers, or UPC codes, only the model numbers. Model numbers: 360741, 360750, 360751, 360755, 360755 Rev B, 360756, and 360757.