Events

Recall of Device Recall CADDSolis ambulatory infusion pumps

According to U.S. Food and Drug Administration, this recall involved a device in United States that was produced by Smiths Medical ASD, Inc..

What is this?

A correction or removal action taken by a manufacturer to address a problem with a medical device. Recalls occur when a medical device is defective, when it could be a risk to health, or when it is both defective and a risk to health.

Learn more about the data here
  • Type of Event
    Recall
  • Event ID
    54482
  • Event Risk Class
    Class 2
  • Event Number
    Z-1082-2010
  • Event Initiated Date
    2010-01-27
  • Event Date Posted
    2010-03-11
  • Event Status
    Terminated
  • Event Country
    United States
  • Event Terminated Date
    2011-12-10
  • Event Source
    USFDA
  • Event Source URL
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=88564
  • Notes / Alerts
    U.S. data is current through June 2018. All of the data comes from the U.S. Food and Drug Administration, except for the category Manufacturer Parent Company.
    The Parent Company was added by ICIJ.
    The parent company information is based on 2017 public records.
  • Extra notes in the data
    Pump, infusion, pca - Product Code MEA
  • 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.
  • 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.

Device

Device Recall CADDSolis ambulatory infusion pumps
  • Model / Serial
    Lot # 0068858-1-1.
  • Product Classification
    General Hospital and Personal Use Devices
  • Device Class
    2
  • Implanted device?
    No
  • Distribution
    United States (KY and OH) and Canada.
  • Product Description
    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.
  • Manufacturer
    Smiths Medical ASD, Inc.

Manufacturer

Smiths Medical ASD, Inc.
  • Manufacturer Address
    Smiths Medical ASD, Inc., 1265 Grey Fox Rd, Saint Paul MN 55112-6929
  • Manufacturer Parent Company (2017)
    Smiths Group Plc
  • Source
    USFDA