Shiley PED3.0 Cuffless Pediatric Tracheostomy Tube, REF 3.0 PED, Sterile. Tyco Healthcare Group LP, Nellcor Puritan Benn
FDA device recall Z-0997-2009 · posted 2009-03-04 · Terminated
Recall details
- Recalling firm
- Covidien Limited
- Reason for recall
- Difficulty inserting an obturator and/or suction catheter into the tracheostomy tube.
- Action taken
- Consignees were sent an "Urgent Device Alert" letter dated 01/14/2009, by mail via Federal Express overnight delivery and instructed to evaluate any of the affected lot numbers of tracheostomy tubes prior to placement into a patient's stoma. If either the obturator or the desired sterile suction catheter does not fit properly into the tube, the tube must not be inserted into the patient. Further instructions are available at Nellcor Technical Services by calling 1-800-635-5267, option 3, then option 1. New product was expected by mid February, 2009, to address the issue.
- Root cause
- Finished device change control
- Status
- Terminated
- Product code
- JOH
- Quantity affected
- 8,931 units
- Distribution
- Nationwide Distribution, including Puerto Rico.
- Date initiated
- 2009-01-14
- Date posted
- 2009-03-04
- Date terminated
- 2012-05-21
- 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 |
|---|---|---|
| MALLINCKRODT SHILEY NEONATAL, PEDIATRIC, LONG PEDIATRIC TRACHEOSTOMY TUBE (K945513) | Mallinckrodt Medical | 1995-01-13 |