Z-2094-2010

Rolko Trapeze handles, part 148671, for use with Care Assist bed P1170 and Hill Rom 1000 bed P1160, Hill Rom...

Name: Z-2094-2010 Rolko Trapeze handles, part 148671, for use with Care Assist bed P1170 and Hill Rom 1000 bed P1160, Hill Rom...
Creator: Hill-Rom, Inc.
Published: 2010-06-11
License: https://open.fda.gov/license/

Hill-Rom Inc. / initiated 2010-06-11 / Terminated / root cause: manufacturing process

FDA source

Hill-Rom, Inc. began a recall of Rolko Trapeze handles, part 148671, for use with Care Assist bed P1170 and Hill Rom 1000 bed P1160, Hill Rom Batesville, IN. Intended Use: The CareAssist and... on 2010-06-11. The reason FDA records is "The firm received a complaint regarding the plastic housing used to support the trapeze handle. The firm investigated and found that the manufacturer of the trapeze handle didn't correctly process the plastic component...". As of 2026-09-10, the recall status on record is Terminated, and MDM tags the root cause as manufacturing process.

Recall record

Recall number: Z-2094-2010
Status: Terminated
Initiated: 2010-06-11
Posted: 2015-06-26
Terminated: 2011-02-18
Recalling firm: Hill-Rom Inc.
Product: Rolko Trapeze handles, part 148671, for use with Care Assist bed P1170 and Hill Rom 1000 bed P1160, Hill Rom Batesville, IN. Intended Use: The CareAssist and Hill-Rom 1000 Beds are intended for low to moderate acuity patients in the medical/surgical area of the Hospital. The Rolko Trapeze handle is used by the patient to help reposition themselves while lying in the bed.
Product code: FNL Bed, Ac-Powered Adjustable Hospital
Reason for recall: The firm received a complaint regarding the plastic housing used to support the trapeze handle. The firm investigated and found that the manufacturer of the trapeze handle didn't correctly process the plastic component. Therefore the plastic had the potential to break prematurely.
Root cause tag: manufacturing process
FDA root cause: Process control
Action: The firm, Hill-Rom, sent an "Urgent Field Safety Notice" letter dated June 11, 2010, to its customers. The letter describes the product, problem and action to be taken by the customers. Hill-Rom provided the quantity of handles needed to replace handles customers received during the affected period. The customers were instructed to immediately remove and replace all Trapeze Handles that were delivered during the affected period; to replace the Trapeze Handle Assemblies (with a manufacturing date from January 2007 to January 2009) used on their Patient Helper with the enclosed unit(s); complete and return the Customer Response Form as soon as possible, or by July 26, 2010; advise the firm immediately if they have relocated the beds and/or the accessories to another location, and forward the letter to any other facility personnel they deem appropriate. If you have any questions concerning this request or the procedure as outlined, please contact Hill-Rom Technical Support at 800-445-3720.
Quantity in commerce: 319
Distribution: Worldwide distribution: USA and Canada.
Product codes and lots: Product has no code.

Product code FNL

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 2026-10-07, the FDA export date for this dataset. Page last changed 2026-09-05. View this recall on fda.gov (opens on fda.gov)