Recall Z-0014-2018 ยท FSA Lift, Patient, Non-Ac-Powered
Handicare AB
Carina Mobile Lifts, Models: a) Carina350EM, REF 6060011 b) Carina350EML, REF 60600012 c) Carina350EE, REF 60600009
| Date | Jul 28, 2016 |
| Status | Terminated |
| Reason | A limited amount of Carina mobile lifts have been delivered with a too small locking pin. If a locking pin smaller than the correct size is mounted on the Carina mobile lift, the locking pin is likely to cause increased wear on the plastic bushings. In case of continued use, these components may cause wear on the metal of the piston rod eye. |
| Root cause | Process control |
| Action | The firm initiated their recall by email on 07/28/2017. The firm directed the consignee to repair the units on site and destroy the affected parts. |
| Quantity | 9 units |
| Distribution | OH, PA, MD |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
This recall record lists no 510(k) number.