Recall Z-1578-2013 ยท FNG Lift, Patient, Ac-Powered
Prism Medical Services USA
Prism Medical C-Series Carry Bar, Class I, model number 360755. The intended use is a carry bar attached to a C-450 or C-625 ceiling lift used to lift, transfer or position clients.
| Date | Jun 21, 2013 (initiated Jan 27, 2013) |
| Status | Terminated |
| Reason | The firm replaced the recalled carry bar with a plastic insert with a carry bar with a metal insert due to improper installation of the recalled carry bars. |
| Root cause | Use error |
| Action | The firm, Prism Medical, sent a letter dated January 27, 2013 to is customers.The letter described the product, problem and actions to be taken. The customers were instructed to perform an immediate safety check checking that both the pin and the plug have been inserted into the carry bar as outlined in the attached User Instruction guide. Prism offered to replace the recalled product with a different product with greater functionality. If you have any questions, contact VP-Global Product Development at 416-726-3107. |
| Quantity | 1131 carry bars/New England |
| Distribution | Worldwide distribution: US (nationwide) and country of: Canada. |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
This recall record lists no 510(k) number.