Recall Z-1351-2019 ยท FSA Lift, Patient, Non-Ac-Powered
Moller Vital
Molift 2-Point sling bar, an accessory for Molift Mover 205. Item nos. 1430016 1430017 1430021
| Date | Feb 4, 2019 |
| Status | Open, Classified |
| Reason | The firm has received 7 reports of malfunction for the device in which the hooks have broken off, potentially leading the sling to slip out of the sling bar and causing the patient to fall. |
| Root cause | Use error |
| Action | On February 4, 2019, the firm notified customers of the recall via Urgent Field Safety Notice letter. The letter alerted customers to the recalled product. The firm stated that all new 2-Point Sling Bars are now equipped with metal alloy hooks instead of the previously used composite hooks. As part of this recall, the firm will replace the recalled devices with the new design. Distributors were asked to do the following: 1) Read the instructions, and complete and return the customer response form 2) Notify affected customers of the recall 3) Review the list of sales records from Etac Supply |
| Quantity | 427 total |
| Distribution | Domestic distribution to Arizona, Delaware, Florida, Georgia, Massachusetts, Ohio, South Carolina, Texas, Washington, and Wisconsin. Foreign distribution to Canada, Asia, Europe, and Australia. |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
This recall record lists no 510(k) number.