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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:
The recall applies to the following 80 lot numbers manufactured in Mexico and distributed in the United States:
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.
Sherri Hughes-Smith Bruce Farmer
Coleman Lannum, CFA Brian Nameth