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.
FDA Recall Z-2047-2009 · Posted 2009-09-08
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Recalling FirmCovidien Limited
Recall StatusTerminated
Product CodeCCK
Date Initiated2009-08-14
Date Terminated2012-06-01
Product Quantity276,390 units
Reason for Recall
CO2 detector may increase resistance to air flow in an intubated patient.
Firm 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.
Root Cause
Component change control
Distribution Pattern
Worldwide Distribution -- US (FL, ID, MD, NC, VA and PA including Puerto Rico), Australia, Belgium, Canada, Japan, Singapore.
Related FDA 510(k) Records
Devices referenced by this recall via K-numbers.
Official Source
View FDA Recall →Source: FDA Enforcement Report / Recall database. Always confirm against the official FDA record.
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