Recall Z-1637-2009 ยท FSA Lift, Patient, Non-Ac-Powered
ArjoHuntleigh
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 requir
| Date | Jul 24, 2009 (initiated Feb 26, 2009) |
| Status | Terminated |
| Reason | 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. |
| 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 |
| Quantity | 103,108 total slings |
| Distribution | Nationwide. |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
This recall record lists no 510(k) number.