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U.S. Department of Health and Human Services

Class 2 Device Recall Rolko Trapeze handles

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  Class 2 Device Recall Rolko Trapeze handles see related information
Date Initiated by Firm June 11, 2010
Create Date June 26, 2015
Recall Status1 Terminated 3 on February 18, 2011
Recall Number Z-2094-2010
Recall Event ID 56033
Product Classification Bed, ac-powered adjustable hospital - Product Code FNL
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.
Code Information Product has no code.
Recalling Firm/
Manufacturer		 Hill-Rom, Inc.
125 E Pearl St
1069 State Route 46 East
Batesville IN 47006
For Additional Information Contact
812-934-7777
Manufacturer 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.
FDA Determined
Cause 2		 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.
Total Product Life Cycle TPLC Device Report
1 A record in this database is created when a firm initiates a correction or removal action. The record is updated if the FDA identifies a violation and classifies the action as a recall, and it is updated for a final time when the recall is terminated. Learn more about medical device recalls.
2 Per FDA policy, recall cause determinations are subject to modification up to the point of termination of the recall.
3 For details about termination of a recall see Code of Federal Regulations (CFR) Title 21 §7.55.
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