—#88564

Product

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. These power cords allow users to run the pump via AC power rather than battery power. The CADD-Solis pump is indicated for intravenous, intra-arterial, subcutaneous, intraperitoneal, in close proximity to nerves, into an intraoperative site (soft tissue, body cavity/ surgical wound site), epidural space, or subarachnoid space infusion. The pump is intended for therapies that require a continuous rate of infusion, patient-controlled demand doses, or both.

FDA product code: MEA — Pump, Infusion, Pca
Device class: Class 2
Medical specialty: General Hospital
510(k) numbers: K072144
Affected lot / code info: Lot # 0068858-1-1.

Why it was recalled

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 (FDA determination)

Nonconforming Material/Component

Action the firm took

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 notice or to report any issues with the affected product, please contact the Smiths Medical Technical Service Department at 1-800-558-2345.

Recalling firm

Firm: Smiths Medical ASD, Inc.
Address: 1265 Grey Fox Rd, Saint Paul, Minnesota 55112-6929

Distribution

Distribution pattern: United States (KY and OH) and Canada.

Timeline

Recall initiated: 2010-01-27
Posted by FDA: 2010-03-11
Terminated: 2011-12-10
Status: —

Source: openFDA Device Recall endpoint. Recall record ID #88564. The FDA issues recall classifications as health-hazard assessments, not legal findings; for legal claims consult a licensed attorney.