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News Release

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Covidien Initiates a Nationwide Voluntary Medical Device Recall of the Pedi-Cap™ End-Tidal CO2 Detector (Pedi-Cap and Pedi-Cap 6)
Boulder, CO. September 2, 2009 – Covidien (formerly known as Tyco Healthcare) has initiated a voluntary nationwide medical device recall of certain lots of the Pedi-Cap™ End-Tidal CO2 Detector (Pedi-Cap and Pedi-Cap 6) due to potential difficulty manually ventilating an intubated patient through the Pedi-Cap. Should ineffective ventilation of the patient and/or inability to detect CO2 levels occur, the indicator paper will not change color.

With respect to the affected units, a modification that was made to the Pedi-Cap End-Tidal CO2 Detector may result in increased resistance to airflow through the Pedi-Cap, which could result in the following:

  • Misinterpretation of high peak pressure;
  • Inappropriate therapeutic intervention; and/or
  • Unnecessary removal of otherwise properly placed endotracheal tube
  • The immediate health consequences that may result from the use of the recalled device include hypoxemia and/or hypercarbia, which in turn may cause serious injury and/or death if not treated appropriately.

    The recall applies to the following 80 lot numbers manufactured in Mexico and distributed in the United States:

    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

    9204128

    Only Pedi-Cap End-Tidal CO2 Detectors (Pedi-Cap and Pedi-Cap 6) from the lot numbers listed above are affected by this action. The lot numbers can be found on the box and on the foil package for each Pedi-Cap. Customers are required to identify, segregate and return any affected products in their inventory.

    The Company has taken appropriate steps to remediate this issue and estimates that new units of the product will be available by the end of September 2009.

    Customers have been notified of this issue by letter on August 14, 2009. To return the affected product for credit, please contact our Technical Services group at 1-800-635-5267, option 3, then option 1, and request a Return Goods Authorization Number (RGA).

    Healthcare professionals and customers may report adverse events or quality problems experienced with the use of this product to the FDA’s MedWatch Adverse Event Reporting program either online, by regular mail, fax or by phone.

    • Online: www.fda.gov/medwatch/report.htm
    • Regular Mail: use postage-paid FDA form 3500 available at: www.fda.gov/MedWatch/getforms.htm.
    • Mail to MedWatch 5600 Fishers Lane, Rockville, MD 20852-9787
    • Fax: 1-800-332-0178
    • Phone: 1-800-332-1088
    •  

      Contacts:

      Sherri Hughes-Smith                                                    Bruce Farmer
      Manager, Media and Public Relations                          Vice President
      Respiratory and Monitoring Solutions                          Public Relations
      303-581-6849                                                              508-452-4372
      sherri.hughes-smith@covidien.com                             bruce.farmer@covidien.com

      Coleman Lannum, CFA                                               Brian Nameth
      Vice President                                                              Director
      Investor Relations                                                        Investor Relations
      508-452-4343                                                              508-452-4363
      cole.lannum@covidien.com                                        brian.nameth@covidien.com