Recall Z-1916-2016 ยท FSA Lift, Patient, Non-Ac-Powered
Hill-Rom, Inc.
Liko Universal SlingBars Universal SlingBar" 350, Universal SlingBar" 350 QRH, Universal SlingBar" 350 R2R, Universal SlingBar" 450, Universal SlingBar" 450 QRH, Universal SlingBar" 450 R2R, Universal SlingBar" 600 Universal SlingBar" 600 QRH Component of Liko Lifts Product Usage: Universal SlingBar 350 It is commonly used for lifting children. Universal SlingBar 350 is available with t
| Date | Jun 7, 2016 (initiated Mar 8, 2016) |
| Status | Terminated |
| Reason | The center bolt of the sling bar, which connects the bar to the patient lift, has failed during use. If the sling bar is not used as intended the bolt may be weakened. If the bolt is weakened there is a potential risk for breakage with the result of a free fall of the patient. This hazard could cause potentially minor to catastrophic injuries to a patient. |
| Root cause | Labeling design |
| Action | On 3/8/2016, MEDICAL DEVICE CORRECTION notifications were sent to the affected US customers via email and courier. On 3/24/2016, MEDICAL DEVICE CORRECTION notifications were sent to the affected Canadian customers via email and courier. On 3/29/2016, MEDICAL DEVICE CORRECTION notifications were sent to the affected Global customers via email and Docapost. The recall notification included a description of the reason for the recall, affected product, consignee responsibilities, and instructions for responding to the formal recall notification. The notification provided new instructio |
| Quantity | 163,561 |
| Distribution | Worldwide and US Nationwide Distribution AE, AO, AR , AT , AU , AZ , BD , BE , BG , BH , BM , BN , BR , CA , CH , CL , CN , CO , CS , CZ , DE , DK , EG , ES , FI , FR , GB , GR , HK , HR , HU , ID , IE , IL , IN , IR , IS , IT , JO , JP , KR , KW , LB , LI , LK , LT , LU , LV , LY , MA , MT , MX , |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
This recall record lists no 510(k) number.