Recall Z-2047-2009 ยท CCK Analyzer, Gas, Carbon-Dioxide, Gaseous-Phase
Covidien Limited
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.
| Date | Sep 8, 2009 (initiated Aug 14, 2009) |
| Status | Terminated |
| Reason | CO2 detector may increase resistance to air flow in an intubated patient. |
| 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 | 276,390 units |
| Distribution | Worldwide Distribution -- US (FL, ID, MD, NC, VA and PA including Puerto Rico), Australia, Belgium, Canada, Japan, Singapore. |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
| K944400 | PEDI-CAP Nellcor, Inc., Sep 27, 1994 |