Recall Z-1234-2008 ยท FSA Lift, Patient, Non-Ac-Powered
Arjo, Inc.
Nautica (GK) Mattress Stretcher, manufactured by Georg Kramer GES.M.B.H. & CO. KG A-4061 PASCH ING, Neuhauserweg 14 Austria. These mattress stretchers were sold for installation on or as a component of the following patient bath lifts: a) Manufactured by BHM Medical Inc., Magog, QC, Canada J1X 5Y5: Part number 88004051, Nautica Bath Lift System; b) Distributed by Whitehall Manufacturing, P.O. Box
| Date | Aug 24, 2008 (initiated Jan 23, 2007) |
| Status | Terminated |
| Reason | Repeated use of the ratchets that lock the position of the back and leg rest of the stretcher may damage the retention pin that prevents the latch from disengaging from the anchor system. This would allow the backrest to pivot freely down to the floor. |
| Root cause | Device Design |
| Action | BHM Medical initially notified the end users on 1/23/07 of the potential for the back and leg rest latch ratchets to become damaged, allowing the rests to pivot freely. Should a patient be in the stretcher at the time, the patient could fall, potentially sustaining cuts, bruises or even more severe injuries. The letters provided safety instructions to follow until a permanent fix is available, and requested the accounts to complete and return the enclosed response form acknowledging receipt of the letter and dissemination of the safety instructions to all employees operating the lifts with t |
| Quantity | 7 units |
| Distribution | Nationwide Distribution --- including states of California, Connecticut, Florida, Mississippi and Texas. |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
This recall record lists no 510(k) number.