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U.S. Department of Health and Human Services

Class 2 Device Recall Flite Clip Slings

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 Class 2 Recall
Flite Clip Slings
see related information
Date Posted July 24, 2009
Recall Status1 Open
Recall Number Z-1637-2009
Recall Event ID 51273
Product Classification Lift, Patient, Non-Ac-Powered - Product Code FSA
Product Flite Clip Slings; patient specific disposable sling; Manufactured in Belgium for Medibo NV, Heikant 5, 3930 Hamont Achel, Belgium; these slings are intended for use with Arjo and BHM Passive Patient Lifts and Ceiling Lifts with four-point hanger bars intended for use with clip slings. The slings are used to assist with the lifting and transportation of a patient in the horizontal or other required position from one place to another and used only by appropriately trained caregivers.
Code Information Model MFA1000M (all slings manufactured prior to March 1, 2009).
Recalling Firm/
Manufacturer
ArjoHuntleigh
2349 W Lake St
Addison, Illinois 60101-6183
Manufacturer Reason
for Recall
If the sling clips are not applied or are applied incorrectly, there is the potential for the patient to fall, resulting in injury to both the patient and/or the caregiver.
FDA Determined
Cause 2
MISBRANDING: Labeling False and Misleading
Action An "Urgent Field Safety Notification" letter dated January 30, 2009 to all customers with ARJO/BHM Passive Patient Lifts and Ceiling Lifts with four-point hanger bars via UPS 2nd day on the February 26, 2009. The notification letter informed the accounts of the potential for clip detachments if the sling clips are not applied to the hanger bar attachment lugs. The accounts were instructed to do the following: 1) Apply the stickers provided to the passive patient lift and/or ceiling lift hanger bars as shown in the enclosed Sticker Application Instructions sheet; 2) Retrain lift operators in accordance with the enclosed instructional DVD, the revised Passive Clip Sling Operating and Product Care Instructions manual and the revised Flites Clip Operating and Product Care Instructions manual; and 3) Make lift operators aware of the Clip Sling/ Flites Clip Application Instructional poster and its location within their facility. The accounts were also instructed to complete and fax back to Arjo the enclosed Customer Response Form, providing the facility name and address, contact name and phone number, acknowledging receipt and understanding of the Field Safety Notice. If you have any questions or require any additional information, contact the ARJO, Inc. Quality, Customer Support, or Technical Support Departments via e-mail at quality@arjousa.com, via phone at 1-800-323-1245, or via fax at 1-888-594-2756.
Quantity in Commerce 103,108 total slings
Distribution Nationwide.
Total Product Life Cycle TPLC Device Report

 
1 For details about termination of a recall see Code of Federal Regulations (CFR) Title 21 §7.55
2 Per FDA policy, recall cause determinations are subject to modification up to the point of termination of the recall.
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