Recall Z-2094-2010 ยท FNL Bed, Ac-Powered Adjustable Hospital
Hill-Rom, Inc.
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.
| Date | Jun 11, 2010 |
| Status | Terminated |
| Reason | 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 | 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); compl |
| Quantity | 319 |
| Distribution | Worldwide distribution: USA and Canada. |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
This recall record lists no 510(k) number.