Recall Z-1990-2009 ยท FNG Lift, Patient, Ac-Powered
B.H.M. Medical, Inc.
BHM Combi Sling, 100% Polyester Shell/100% Polyester Strap; soft polyester net fabric sling for ceiling and floor patient lifts; BHM, Magog, Canada, made in China. Part 626002: Combi Deluxe - Medium, capacity 68-113 kg, 150-250 lbs; Part 626002M: Combi Mesh Deluxe - Medium, capacity 68-113 kg, 150-250 lbs; Part 626002C Combi Sling Deluxe Small, capacity 20-68 kg, 45-150 lbs; Part 626002C-M Com
| Date | Aug 31, 2009 (initiated Apr 7, 2009) |
| Status | Terminated |
| Reason | Premature failure of the stitching at the junction of the shoulder strap and sling body of the BHM/Medi-Man Combi Sling used with patient lifts. |
| Root cause | Device Design |
| Action | Arjo sent "Urgent Device Recall Customer Notification" cover letters dated April 15, 2009 to the end user accounts who received the affected BHM/Medi-Man Combi Slings, to the attention of the Administrator/Risk Manager, advising them of the potential for possible stitching failure that could lead to a hazardous situation. Enclosed with the letter was a copy of the BHM Medical Field Safety Notice, FSN 10/2009/ca, dated April 3, 2009 which was sent to their BHM customers in the U.S. on April 7, 2009. The FSN identified the part numbers of the BHM/Medi-Man Combi Slings, described the potential he |
| Quantity | 1,396 slings |
| Distribution | Nationwide |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
This recall record lists no 510(k) number.