Class 2 Device Recall BHM Reacher for Portable Ceiling Lifts

• Date Initiated by Firm: November 13, 2006
• Date Posted: January 11, 2007
• Recall Status: Terminated on January 19, 2010
• Recall Number: Z-0482-2007
• Recall Event ID: 36802
• Product Classification: patient lift accessory - Product Code FSA
• Product: BHM Reacher for Portable Ceiling Lifts; a portable ceiling lift accessory used to connect the lift to the BHM Track or KwikTrak Trolley; Manufactured by BMH Medical Inc., 2001 Tanguay Street , Magog, Quebec, Canada J1X 5Y5. The reacher comes in two models: part #700.08310 - 24'' handle length, and part #700.08320 - 36'' handle length
• Code Information: Part #700.08310 - 24'' handle length, and part #700.08320 - 36'' handle length, all reachers shipped between November 2003 through November 6, 2006.
• Recalling Firm/ Manufacturer: Arjo, Inc.; 50 Gary Ave Ste A; Roselle IL 60172-1684
• For Additional Information Contact: Ms. Traci Giovenco; 800-323-1245
• Manufacturer Reason for Recall: The carabineer may not be correctly attached to the reacher and the portable patient lift may drop.
• FDA Determined Cause: Other
• Action: BHM sent recall letters to Arjo''s direct accounts on 11/13/06 via first class mail, informing them that fastening the carabineer to the exterior of the closed ring portion of the reacher is contrary to the manufacturer''s instructions and is an unsafe practice. The letters informed the users that Health Canada had received notification of an incident involving a reacher marketed by a competitor, and had conducted an investigation into all similar reachers available on the Canadian market. Enclosed with the letter was a copy of the BHM Reacher User''s Guide as well as a warning sticker that visually describes the safe method for connecting the carabineer to the reacher. The accounts were requested to place the warning stickers on their reachers, review the enclosed User''s Guide in detail, and ensure that all personnel using the reacher receive refresher training on its proper use and have access to the supplied User''s Guide. Once these measures have been completed, the account was requested to complete the enclosed response form and return it to BHM by fax, e-mail or mail.
• Quantity in Commerce: 886 reachers
• Distribution: Nationwide
• 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.