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U.S. Department of Health and Human Services

Class 1 Device Recall PediCap CO2 Detector

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  Class 1 Device Recall PediCap CO2 Detector see related information
Date Initiated by Firm August 14, 2009
Date Posted September 08, 2009
Recall Status1 Terminated 3 on June 01, 2012
Recall Number Z-2047-2009
Recall Event ID 52927
510(K)Number K944400  
Product Classification Analyzer, gas, carbon-dioxide, gaseous-phase - Product Code CCK
Product Pedi-Cap CO2 Detector, 1 kg - 15 kg, Tyco Healthcare Group LP, Nellcor Puritan Bennett Division, Pleasanton, CA. Assembled in Mexico. Sold in packages of 6 (PediCap6) or 24 (PediCap).

Intended for use during endotracheal or nasotracheal intubation to assist in verification of tube placement.
Code Information Lot Numbers: 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 and 9204128.
Recalling Firm/
Manufacturer		 Covidien Limited
6135 Gunbarrel Ave
Boulder CO 80301-3214
For Additional Information Contact
303-305-2382
Manufacturer Reason
for Recall		 CO2 detector may increase resistance to air flow in an intubated patient.
FDA Determined
Cause 2		 Component change control
Action Covidien issued an Urgent Medical Device Recall letter dated August 14, 2009 informing Consignees of the affected devices. Users were told to stop use and arrange for return of all affected product. For further information, contact Covidien at 1-800-635-5267.
Quantity in Commerce 276,390 units
Distribution Worldwide Distribution -- US (FL, ID, MD, NC, VA and PA including Puerto Rico), Australia, Belgium, Canada, Japan, Singapore.
Total Product Life Cycle TPLC Device Report
1 A record in this database is created when a firm initiates a correction or removal action. The record is updated if the FDA identifies a violation and classifies the action as a recall, and it is updated for a final time when the recall is terminated. Learn more about medical device recalls.
2 Per FDA policy, recall cause determinations are subject to modification up to the point of termination of the recall.
3 For details about termination of a recall see Code of Federal Regulations (CFR) Title 21 §7.55.
510(K) Database 510(K)s with Product Code = CCK and Original Applicant = NELLCOR, INC.
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