Z-1637-2009

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

Name: Z-1637-2009 Flite Clip Slings; patient specific disposable sling; Manufactured in Belgium for Medibo NV, Heikant 5, 3930...
Creator: ArjoHuntleigh
Published: 2009-02-26
License: https://open.fda.gov/license/

Arjohuntleigh AB / initiated 2009-02-26 / Terminated

FDA source

ArjoHuntleigh began a recall of Flite Clip Slings; patient specific disposable sling; Manufactured in Belgium for Medibo NV, Heikant 5, 3930 Hamont Achel, Belgium; these slings are intended... on 2009-02-26. The reason FDA records is "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". As of 2026-09-10, the recall status on record is Terminated.

Recall record

Recall number: Z-1637-2009
Status: Terminated
Initiated: 2009-02-26
Posted: 2009-07-24
Terminated: 2011-02-25
Recalling firm: Arjohuntleigh AB
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.
Product code: FSA Lift, Patient, Non-Ac-Powered
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 root cause: Other
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 [email protected], via phone at 1-800-323-1245, or via fax at 1-888-594-2756.
Quantity in commerce: 103,108 total slings
Distribution: Nationwide.
Product codes and lots: Model MFA1000M (all slings manufactured prior to March 1, 2009).

Product code FSA

The FDA recall record names no cleared device, and no clearance has been matched to it.

MDM coverage of this record lists here, newest first.

About this record

Sourced from the FDA device recall database and the FDA enforcement reports, both ingested from openFDA. The recall record supplies the product, the reason and the product code; the enforcement report supplies the classification. The two datasets are exported by FDA on different days, and the date above is the older of the two, so nothing on this page is newer than it says.

MDM adds the root cause tag, derived from FDA’s own root cause text, and the cross-links to the product code, the clearances named on the record and MDM coverage. Where a recall has not been joined to an enforcement report, no classification is shown.

Data as of 2026-09-30, the FDA export date for this dataset. Page last changed 2026-09-05. View this recall on fda.gov (opens on fda.gov)