Recall Z-1913-2011 ยท FNG Lift, Patient, Ac-Powered
Penner Mfg Inc
Penner Manufacturing Bariatric Patient Transfer/Lift System, Cascade Transfer, Models 382500-1 (right entry). The firm name on the label is Penner Manufacturing Inc., Aurora, NE. For use with bathing systems in nursing homes, hospitals, and assisted living facilities to transfer or lift patients under the direct supervision of trained staff.
| Date | Apr 8, 2011 (initiated Jan 19, 2009) |
| Status | Terminated |
| Reason | Incomplete weld on the pillar mounting bracket |
| Root cause | Employee error |
| Action | The firm, Penner, sent an undated letter flagged "Important Safety Inspection: Action Required" via certified mail on January 19, 2009 to its customers. The letter described the product, problem and actions to be taken. The customers were instructed to inspect the Penner Patient Transfer for any missing Welds of the Pillar Mounting Bracket; inspect the areas indicated in the enclosed photos to confirm the bracket is welded on all edges to the main frame of the base; complete the inspection, and complete and return the attached WELD INSPECTION RESULTS OF PENNER PATIENT TRANSFER form via fax t |
| Quantity | 10 lifts |
| Distribution | Worldwide distribution: USA and countries including: Canada and Mexico. |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
This recall record lists no 510(k) number.