Z-0728-2017Class II

Carry bar which is an accessory to a lift used for patients in hospitals and other facilities. Recall impacts...

Name: Z-0728-2017 Carry bar which is an accessory to a lift used for patients in hospitals and other facilities. Recall impacts...
Creator: ErgoSafe Products, LLC (DBA) Prism Medical
Published: 2016-08-30
License: https://open.fda.gov/license/

Handicare USA, Inc. / initiated 2016-08-30 / Terminated / root cause: design

FDA source

ErgoSafe Products, LLC (DBA) Prism Medical began a recall of 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... on 2016-08-30. FDA classified it as Class II and gives the reason as "The black plastic puck on the carry bar is breaking resulting in potential for patient harm". As of 2026-09-10, the recall status on record is Terminated, and MDM tags the root cause as design.

Recall record

Recall number: Z-0728-2017
Classification: Class II
Status: Terminated
Initiated: 2016-08-30
Posted: 2016-12-09
Terminated: 2018-07-18
Recalling firm: Handicare USA, Inc.
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.
Product code: FSA Lift, Patient, Non-Ac-Powered
Reason for recall: The black plastic puck on the carry bar is breaking resulting in potential for patient harm.
Root cause tag: design
FDA 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 in commerce: not greater than 17,964 units
Distribution: Distributed US nationwide and to Canada, Japan, Australia, Thailand, Great Britain, and South Korea
Product codes and lots: 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.

Enforcement reports

One row per recalled product line

FDA enforcement reports joined to recall event Z-0728-2017
Recall number	Class	Status	Voluntary or mandated	Report date	Classified
Z-0728-2017	Class II	Terminated	Voluntary: Firm initiated	2016-12-21	2016-12-09

Product code FSA

The FDA recall record names no cleared device, and no clearance has been matched to it.

MDM coverage of this record lists here, newest first.

About this record

Sourced from the FDA device recall database and the FDA enforcement reports, both ingested from openFDA. The recall record supplies the product, the reason and the product code; the enforcement report supplies the classification. The two datasets are exported by FDA on different days, and the date above is the older of the two, so nothing on this page is newer than it says.

MDM adds the root cause tag, derived from FDA’s own root cause text, and the cross-links to the product code, the clearances named on the record and MDM coverage. Where a recall has not been joined to an enforcement report, no classification is shown.

Data as of 2026-09-30, the FDA export date for this dataset. Page last changed 2026-09-05. View this recall on fda.gov (opens on fda.gov)