Recall Z-0728-2017 ยท FSA Lift, Patient, Non-Ac-Powered
ErgoSafe Products, LLC (DBA) Prism Medical
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.
| Date | Aug 30, 2016 |
| Status | Terminated |
| Reason | The black plastic puck on the carry bar is breaking resulting in potential for patient harm. |
| Root cause | Device Design |
| Action | The recalling firm sent field safety notices to their customers by mail on August 30, 2016. The notice instructed customers to inspect their carry bar to see if it used a black plastic puck. If it did, they were instructed to contact the recalling firm to receive a metal insert to install. If the puck is cracked or damaged, they can request a new, replacement carry bar at a discounted price. For further questions, please call (866) 891-6502. |
| Quantity | not greater than 17,964 units |
| Distribution | Distributed US nationwide and to Canada, Japan, Australia, Thailand, Great Britain, and South Korea |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
This recall record lists no 510(k) number.