Z-1082-2010

Electri-Cord AC Power Cords, IEC 60320 Coupler, Product Reorder Number 21-2145-01 only for use with Smiths...

Name: Z-1082-2010 Electri-Cord AC Power Cords, IEC 60320 Coupler, Product Reorder Number 21-2145-01 only for use with Smiths...
Creator: Smiths Medical ASD, Inc.
Published: 2010-01-27
License: https://open.fda.gov/license/

Abbott Medical / initiated 2010-01-27 / Terminated / root cause: manufacturing process

FDA source

Smiths Medical ASD, Inc. began a recall of 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... on 2010-01-27. The reason FDA records is "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...". As of 2026-09-10, the recall status on record is Terminated, and MDM tags the root cause as manufacturing process.

Recall record

Recall number: Z-1082-2010
Status: Terminated
Initiated: 2010-01-27
Posted: 2010-03-11
Terminated: 2011-12-10
Recalling firm: Abbott Medical
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.
Product code: MEA Pump, Infusion, Pca
Reason for recall: 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 tag: manufacturing process
FDA 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 notice or to report any issues with the affected product, please contact the Smiths Medical Technical Service Department at 1-800-558-2345.
Quantity in commerce: 62
Distribution: United States (KY and OH) and Canada.
Product codes and lots: Lot # 0068858-1-1.

Product code MEA

K072144Class IICadd -Solis Ambulatory Infusion Pump and Cadd -Solis Medication Safety Software - AdministratorSmiths Medical MD, Inc. / cleared 2008-03-07

MDM coverage of this record lists here, newest first.

About this record

Sourced from the FDA device recall database and the FDA enforcement reports, both ingested from openFDA. The recall record supplies the product, the reason and the product code; the enforcement report supplies the classification. The two datasets are exported by FDA on different days, and the date above is the older of the two, so nothing on this page is newer than it says.

MDM adds the root cause tag, derived from FDA’s own root cause text, and the cross-links to the product code, the clearances named on the record and MDM coverage. Where a recall has not been joined to an enforcement report, no classification is shown.

Data as of 2026-10-07, the FDA export date for this dataset. Page last changed 2026-09-05. View this recall on fda.gov (opens on fda.gov)