Recall Z-0997-2009 ยท JOH Tube Tracheostomy And Tube Cuff
Covidien Limited
Shiley PED3.0 Cuffless Pediatric Tracheostomy Tube, REF 3.0 PED, Sterile. Tyco Healthcare Group LP, Nellcor Puritan Bennett Division, Pleasanton, CA. Assembled in Mexico. The product is provided as one each shipped in an inner carton to end customers. The intended use of the device is to bypass upper airway obstructions, provide long term ventilation, and support and/or manage tracheal/bronchi
| Date | Mar 4, 2009 (initiated Jan 14, 2009) |
| Status | Terminated |
| Reason | Difficulty inserting an obturator and/or suction catheter into the tracheostomy tube. |
| Root cause | Finished device change control |
| Action | 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. |
| Quantity | 8,931 units |
| Distribution | Nationwide Distribution, including Puerto Rico. |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
| K945513 | MALLINCKRODT SHILEY NEONATAL, PEDIATRIC, LONG PEDIATRIC TRACHEOSTOMY TUBE Mallinckrodt Medical, Jan 13, 1995 |