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