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.
This recall has been terminated (originally issued September 8, 2009).
- Company
- Covidien Limited
- Recall Initiated
- August 14, 2009
- Posted
- September 8, 2009
- Terminated
- June 1, 2012
- Recall Number
- Z-2047-2009
- Quantity
- 276,390 units
- Firm Location
- Boulder, CO
- Official Source
- View on FDA website ↗
Reason for Recall
CO2 detector may increase resistance to air flow in an intubated patient.
Distribution
Worldwide Distribution -- US (FL, ID, MD, NC, VA and PA including Puerto Rico), Australia, Belgium, Canada, Japan, Singapore.
Lot / Code Info
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.
Root Cause
Component change control
Action Taken
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.