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Recall Observatory FDA recall evidence

Device 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.

Z-0728-2017

August 30, 2016

Class II

Product summary

Firm
ErgoSafe Products, LLC (DBA) Prism Medical
Event
Event 74488
Status
Terminated
Classification
Class II
Quantity
not greater than 17,964 units
Official record key
device-enforcement:Z-0728-2017

Official wording

Reason: The black plastic puck on the carry bar is breaking resulting in potential for patient harm.

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.

Distribution pattern: Distributed US nationwide and to Canada, Japan, Australia, Thailand, Great Britain, and South Korea

Derived failure modes

  • Unknown

    reason.no_named_rule · v1.0.0

    The black plastic puck on the carry bar is breaking resulting in potential for patient harm.