Recall Z-2470-2021 ยท FSA Lift, Patient, Non-Ac-Powered
Getinge Dominican Republic SA
Arjo Disposable Repositioning Sling, Model AHD001
| Date | Jul 30, 2021 |
| Status | Terminated |
| Reason | Sling loop straps on device pose a trip hazard. |
| Root cause | Device Design |
| Action | The Field Safety Notification (FSN) will be accompanied by a Customer Response Form. The customer will be asked to acknowledge the FSN reception, complete and sign an enclosed Customer Response Form and return it to the local Arjo office (address indicated in the FSN) in order to confirm that the caution and additionally provided instructions are understood and followed by personnel. |
| Quantity | 46,085 units |
| Distribution | US Nationwide distribution in the states of AL, AR, AZ, CA, CO, CT, FL, GA, IA, IL, IN, KS, KY, MD, ME, MI, MN, MO, MS, NC, ND, NJ, NM, NY, OH, OR, PA, SC, TN, TX, VA, VT, WI, and WV. |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
This recall record lists no 510(k) number.