Z-2047-2009

Pedi-Cap CO2 Detector, 1 kg - 15 kg, Tyco Healthcare Group LP, Nellcor Puritan Bennett Division, Pleasanton...

Name: Z-2047-2009 Pedi-Cap CO2 Detector, 1 kg - 15 kg, Tyco Healthcare Group LP, Nellcor Puritan Bennett Division, Pleasanton...
Creator: Covidien Limited
Published: 2009-08-14
License: https://open.fda.gov/license/

Medtronic, Inc. / initiated 2009-08-14 / Terminated

FDA source

Covidien Limited began a recall of 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... on 2009-08-14. The reason FDA records is "CO2 detector may increase resistance to air flow in an intubated patient". As of 2026-09-10, the recall status on record is Terminated.

Recall record

Recall number: Z-2047-2009
Status: Terminated
Initiated: 2009-08-14
Posted: 2009-09-08
Terminated: 2012-06-01
Recalling firm: Medtronic, Inc.
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.
Product code: CCK Analyzer, Gas, Carbon-Dioxide, Gaseous-Phase
Reason for recall: CO2 detector may increase resistance to air flow in an intubated patient.
FDA root cause: 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.
Product codes and lots: 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.

Product code CCK

K944400Class IIPedi-CapNellcor, Inc. / cleared 1994-09-27

MDM coverage of this record lists here, newest first.

About this record

Sourced from the FDA device recall database and the FDA enforcement reports, both ingested from openFDA. The recall record supplies the product, the reason and the product code; the enforcement report supplies the classification. The two datasets are exported by FDA on different days, and the date above is the older of the two, so nothing on this page is newer than it says.

MDM adds the root cause tag, derived from FDA’s own root cause text, and the cross-links to the product code, the clearances named on the record and MDM coverage. Where a recall has not been joined to an enforcement report, no classification is shown.

Data as of 2026-10-07, the FDA export date for this dataset. Page last changed 2026-09-05. View this recall on fda.gov (opens on fda.gov)