Recall Z-0662-2010 ยท IOQ Bed, Flotation Therapy, Powered
KCI USA, Inc.
AC Power Cords, 110V Manufactured by Electri-Cord Manufacturing Company in Westfield, PA. Power Cord #4100079 used with Kinair IV Model 22600, Kinair IV 60601 Model 216050, Triadyne Proventa Model 406000, Therapulse ATP/II Models 227800 and 227080.S, Kinair Medsurg Model 201001W, and Kinair Medsurg Pulse Model 40900.
| Date | Jan 25, 2010 (initiated Nov 4, 2009) |
| Status | Terminated |
| Reason | Power cords may crack and fail inside plug with potential for fire hazard. |
| Root cause | Nonconforming Material/Component |
| Action | Kinetics Concepts, Inc. (KCI) issued an "Urgent Medical Device Correction" letter dated November 4, 2009. Consignees were informed of the affected product and instructed to take necessary action to avoid any further issues associated with the product. For further information, contact KCI's technical support team at 1-800-275-4524 option #3. |
| Quantity | 4,637 units |
| Distribution | Nationwide and Canada |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
This recall record lists no 510(k) number.