Pedi-Cap CO2 Detector, 1 kg - 15 kg, Tyco Healthcare Group LP, Nellcor Puritan Bennett Division, Pleasanton, CA. Assembl
FDA device recall Z-2047-2009 · posted 2009-09-08 · Terminated
Recall details
- Recalling firm
- Covidien Limited
- Reason for recall
- CO2 detector may increase resistance to air flow in an intubated patient.
- 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.
- Root cause
- Component change control
- Status
- Terminated
- Product code
- CCK
- Quantity affected
- 276,390 units
- Distribution
- Worldwide Distribution -- US (FL, ID, MD, NC, VA and PA including Puerto Rico), Australia, Belgium, Canada, Japan, Singapore.
- Date initiated
- 2009-08-14
- Date posted
- 2009-09-08
- Date terminated
- 2012-06-01
- Location
- Boulder, CO
Monitor recalls programmatically
Recalls and clearances share one API, with change alerts when new recalls post.
Related 510(k) clearances
| Record | Firm | Date |
|---|---|---|
| PEDI-CAP (K944400) | Nellcor, Inc. | 1994-09-27 |