Events

Recall of PediCap CO2 Detector

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

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
    52927
  • Event Risk Class
    Class 1
  • Event Number
    Z-2047-2009
  • Event Initiated Date
    2009-08-14
  • Event Date Posted
    2009-09-08
  • Event Status
    Terminated
  • Event Country
    United States
  • Event Terminated Date
    2012-06-01
  • Event Source
    USFDA
  • Event Source URL
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=84290
  • 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
    Analyzer, gas, carbon-dioxide, gaseous-phase - Product Code CCK
  • Reason
    Co2 detector may increase resistance to air flow in an intubated patient.
  • Action
    Covidien issued an Urgent Medical Device Recall letter dated August 14, 2009 informing Consignees of the affected devices. Users were told to stop use and arrange for return of all affected product. For further information, contact Covidien at 1-800-635-5267.

Device

PediCap CO2 Detector
  • Model / Serial
    Lot Numbers: 8294199, 8301112, 8301113, 8315189, 8315190, 8319262, 8319263, 8322181, 8322182, 8326251, 8326252, 8326253, 8326254, 8329072, 8329073, 8330001, 8333183, 8350018, 8350019, 8354221, 8354224, 8357021, 8357022, 8361153, 9005011, 9005012, 9012058, 9012059, 9026042, 9026043, 9033128, 9033129, 9040067, 9040068, 9047127, 9047128, 9054110, 9054111, 9061066, 9061067, 9065209, 9068061, 9068062, 9072281, 9075059, 9075060, 9079160, 9082376, 9082377, 9086312, 9089126, 9089127, 9103038, 9103039, 9110481, 9110482, 9117039, 9117040, 9124134, 9124135, 9131188, 9131189, 9138084, 9138085, 9138226, 9145088, 9145089, 9152238, 9152239, 9159128, 9159129, 9170191, 9170192, 9170197, 9176471, 9176477, 9184145, 9191233, 9191234 and 9204128.
  • Product Classification
    Anesthesiology Devices
  • Device Class
    2
  • Implanted device?
    No
  • Distribution
    Worldwide Distribution -- US (FL, ID, MD, NC, VA and PA including Puerto Rico), Australia, Belgium, Canada, Japan, Singapore.
  • Product Description
    Pedi-Cap CO2 Detector, 1 kg - 15 kg, Tyco Healthcare Group LP, Nellcor Puritan Bennett Division, Pleasanton, CA. Assembled in Mexico. Sold in packages of 6 (PediCap6) or 24 (PediCap). || Intended for use during endotracheal or nasotracheal intubation to assist in verification of tube placement.
  • Manufacturer
    Covidien Limited

Manufacturer

Covidien Limited
  • Manufacturer Address
    Covidien Limited, 6135 Gunbarrel Ave, Boulder CO 80301-3214
  • 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