Z-1578-2013Class II

Prism Medical C-Series Carry Bar, Class I, model number 360755. The intended use is a carry bar attached to a...

Name: Z-1578-2013 Prism Medical C-Series Carry Bar, Class I, model number 360755. The intended use is a carry bar attached to a...
Creator: Prism Medical Services USA
Published: 2013-01-27
License: https://open.fda.gov/license/

Handicare USA, Inc. / initiated 2013-01-27 / Terminated

FDA source

Prism Medical Services USA began a recall of Prism Medical C-Series Carry Bar, Class I, model number 360755. The intended use is a carry bar attached to a C-450 or C-625 ceiling lift used to lift... on 2013-01-27. FDA classified it as Class II and gives the reason as "The firm replaced the recalled carry bar with a plastic insert with a carry bar with a metal insert due to improper installation of the recalled carry bars". As of 2026-09-10, the recall status on record is Terminated.

Recall record

Recall number: Z-1578-2013
Classification: Class II
Status: Terminated
Initiated: 2013-01-27
Posted: 2013-06-21
Terminated: 2018-07-18
Recalling firm: Handicare USA, Inc.
Product: Prism Medical C-Series Carry Bar, Class I, model number 360755. The intended use is a carry bar attached to a C-450 or C-625 ceiling lift used to lift, transfer or position clients.
Product code: FNG Lift, Patient, Ac-Powered
Reason for recall: The firm replaced the recalled carry bar with a plastic insert with a carry bar with a metal insert due to improper installation of the recalled carry bars.
FDA root cause: Use error
Action: The firm, Prism Medical, sent a letter dated January 27, 2013 to is customers.The letter described the product, problem and actions to be taken. The customers were instructed to perform an immediate safety check checking that both the pin and the plug have been inserted into the carry bar as outlined in the attached User Instruction guide. Prism offered to replace the recalled product with a different product with greater functionality. If you have any questions, contact VP-Global Product Development at 416-726-3107.
Quantity in commerce: 1131 carry bars/New England
Distribution: Worldwide distribution: US (nationwide) and country of: Canada.
Product codes and lots: model number 360755

Enforcement reports

One row per recalled product line

FDA enforcement reports joined to recall event Z-1578-2013
Recall number	Class	Status	Voluntary or mandated	Report date	Classified
Z-1578-2013	Class II	Terminated	Voluntary: Firm initiated	2013-07-03	2013-06-21

Product code FNG

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)