Recall Z-1082-2010 ยท MEA Pump, Infusion, Pca
Smiths Medical ASD, Inc.
Electri-Cord AC Power Cords, IEC 60320 Coupler, Product Reorder Number 21-2145-01 only for use with Smiths Medical CADD-Solis ambulatory infusion pumps, Model 2100. These cords were sold as an accessory for these pumps under Manufacturing Number A23.164.098.0A, Electri-Cord part Number PC2000403. Electri-Cord AC Power Cords are accessories for use with the CADD-Solis Ambulatory Infusion Pump. Th
| Date | Mar 11, 2010 (initiated Jan 27, 2010) |
| Status | Terminated |
| Reason | Potential for the power cord's prongs to crack and fail at/or inside the plug. Other medical device manufacturers have reported incidents of sparking, charring, and fires from the affected power cords used with their devices. Smiths Medical has received no reports of incidents regarding the use of the affected Electri-Cord power cords with their devices. |
| Root cause | Nonconforming Material/Component |
| Action | Consignees were sent a Smiths Medical, Inc. "Urgent Medical Device Recall" letter dated January 27, 2010. The letter was addressed to Risk/Safety Managers, Clinicians, Critical Care Physicians, Pediatricians, Pediatric Intensivists, Nenatologists, and Nursing, Pharmacy, Clinical/Biomedical Engineering, and Anesthesia Professionals. The letter described the problem, products involved and provided "Advice on Action to be Taken by the User". Consignees were requested to complete and return the "Urgent Recall Notice Confirmation Form". To return Power Cords, for questions regarding the recall no |
| Quantity | 62 |
| Distribution | United States (KY and OH) and Canada. |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
| K072144 | CADD -SOLIS AMBULATORY INFUSION PUMP AND CADD -SOLIS MEDICATION SAFETY SOFTWARE - ADMINISTRATOR Smiths Medical MD, Inc., Mar 7, 2008 |