Flite Clip Slings; patient specific disposable sling; Manufactured in Belgium for Medibo NV, Heikant 5, 3930 Hamont Ache

FDA device recall Z-1637-2009 · posted 2009-07-24 · Terminated

Recall details

Recalling firm

ArjoHuntleigh

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.

Action taken

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.

Root cause

Other

Status

Terminated

Product code

FSA

Quantity affected

103,108 total slings

Distribution

Nationwide.

Date initiated

2009-02-26

Date posted

2009-07-24

Date terminated

2011-02-25

Location

Addison, IL