Covidien Pedi-Cap End-Tidal CO2 Detector
|Recall Class:||Class I|
|July 17, 2009|
Pedi-Cap End-Tidal CO2 Detector (Pedi-Cap and Pedi-Cap 6)
Only Pedi-Cap End-Tidal CO2 Detectors (Pedi-Cap and Pedi-Cap 6) from the lot numbers listed below are affected by this recall.
|Use:||This device is used in pediatric patients, weighing 2.2-33 pounds, during the process of exchanging oxygen for carbon dioxide (ventilation) in healthcare settings.|
6135 Gunbarrel Avenue
Boulder, Colorado 80301-3214
|Reason for Recall:||This device may increase the resistance of the flow of air into the lungs, resulting in ineffective ventilation and the inability to verify the correct placement of a breathing tube when inserting it into the windpipe. This problem may mimic the signs and symptoms of other medical conditions such as the presence of air or gas in the cavity of the membranes surrounding the lungs. There is a reasonable probability that use of the recalled PediCap will cause serious adverse health consequences or death.|
The company’s Technical Services Group may be reached at 1-800-635-5267, option 3, then option 1.
For more information, see Useful Links below.
On August 14, 2009, the company sent a letter to their distributors/customers informing them to stop selling/using the affected devices and to return them to the company. The company has taken steps to resolve this problem and expects to have modified devices available by the end of September, 2009.
This recall will not cause a device shortage as other companies manufacture CO2 detectors.
Class I recalls are the most serious type of recall and involve situations in which there is a reasonable probability that use of these products will cause serious injury or death.
Health care professionals and consumers may report adverse reactions or quality problems experienced with the use of these products to the FDA's MedWatch Adverse Event Reporting program either online, by regular mail or by FAX.