Recall Z-0664-2010 ยท IKY Mattress, Flotation Therapy, Non-Powered
KCI USA, Inc.
AC Power Cords, 110V Manufactured by Electri-Cord Manufacturing Company in Westfield, PA. Power Cord #M4268840 used with First Step All-In-One Canadian French Models 227500-09 and 227500, First Step All-In-One English Model 227500, Therakair Visio Models M8259978 and M6257763 pump only, and Proficare - Canada Model M8259988
| 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 | 1,384 |
| 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.