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U.S. Department of Health and Human Services

Medical Devices

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Covidien Pedi-Cap End-Tidal CO2 Detector

Recall Class: Class I
Date Recall
Initiated:		 July 17, 2009
Product:

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.

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
These devices were manufactured November 1, 2008 through July 24, 2009 and distributed from November 1, 2008 through July 31, 2009.
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.
Recalling Firm: Covidien
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.
Public Contact:

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.
FDA District: Denver
FDA Comments:

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.

Useful Links:
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