Recall Z-0728-2017— ErgoSafe Products, LLC (DBA) Prism Medical
Class II · Terminated
Class II FDA medical device recall by ErgoSafe Products, LLC (DBA) Prism Medical, initiated 2016-08-30, terminated 2018-07-18. FDA's recall record names no specific 510(k) clearance for this event. Product: 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: The black plastic puck on the carry bar is breaking resulting in potential for patient harm..
- Recalling firm
- ErgoSafe Products, LLC (DBA) Prism Medical
- Classification
- Class II
- Status
- Terminated
- Initiated
- 2016-08-30
- Terminated
- 2018-07-18
- Firm location
- Maryland Heights, MO, United States
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.
Data sourced from openFDA. This site is unofficial and independent of the FDA.