Events

Recall of Device Recall Vistec TM XRay Detectable Sponges

According to U.S. Food and Drug Administration, this recall involved a device in United States that was produced by Covidien LP.

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
    78968
  • Event Risk Class
    Class 2
  • Event Number
    Z-0534-2018
  • Event Initiated Date
    2017-07-17
  • Event Status
    Open, Classified
  • Event Country
    United States
  • Event Source
    USFDA
  • Event Source URL
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=160979
  • 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
    Gauze/sponge, internal, x-ray detectable - Product Code GDY
  • Reason
    Medtronic is voluntarily recalling two production lots of its covidien vistec" x-ray detectable sponges de to possible contamination with human blood caused by handling of the product during the manufacturing process and prior to final packaging and ethylene oxide sterilization.
  • Action
    Medtronic sent an Urgent Medical Device Recall letter dated July 17, 2017 to their customers via Federal Express or certified mail. The letter identified the affected product, problem and actions to be taken. Customers are requested to quarantine, discontinue use and return affected product. Customers were instructed to acknowledge receipt of the Urgent Field Corrective Action Notice. For questions contact your Medtronic representative or Customer Service at 800-962-9888, option 2.

Device

Device Recall Vistec TM XRay Detectable Sponges
  • Model / Serial
    Lot Numbers: 17E121362, 17E121262 UDI: 10884527016990; 20884527016997
  • Product Classification
    General and Plastic Surgery Devices
  • Device Class
    1
  • Implanted device?
    No
  • Distribution
    U.S., Gov Accts, and foreign countries: PA, PR, CO.
  • Product Description
    Covidien Vistec" X-Ray Detectable Sponges, 7317 Vistec" X-Ray Detectable Sponges Sponge. || product Usage: || Vistec X-Ray Detectable Sponges are medical absorbent devices intended to be used internally within the body cavity to control bleeding or for applying medication. These sponges contain unique dual-colored elements that combines blue radiopaque strand with white strand, which is visible when sponge is saturated with blood.
  • Manufacturer
    Covidien LP

Manufacturer

Covidien LP
  • Manufacturer Address
    Covidien LP, 1430 Marvin Griffin Rd, Augusta GA 30906-3851
  • Manufacturer Parent Company (2017)
    Medtronic plc
  • Manufacturer comment
    “If our surveillance systems identify a potential performance issue, our personnel promptly evaluate the problem, including, when appropriate, conducting root cause investigations and internal testing to assess whether the product continues to meet specifications and defined performance criteria,” Medtronic told ICIJ in a statement. “In some cases, based on this evaluation, Medtronic may determine that a recall is necessary.” The company said that it communicates with healthcare providers and/or patients and provide recommendations to address such issues. Medtronic noted that these communications can include letters, emails, calls, press releases, physician notifications and social media postings, as well as informing the FDA and other regulators of the actions.
  • Source
    USFDA