Recall Z-0582-05 ยท BTR Tube, Tracheal (W/Wo Connector)
Teleflex Medical
Novaplus Sheridan/HVT Cuffed, Murphy Eye Tracheal Tube; an Rx, ETO sterilized, single use device inserted into the patient's trachea via the mouth to maintain an open airway; Hudson RCI, Temecula, CA 92589-9020, Manufactured in Mexico, Catalog number (REF) V5-10316 (8.0 mm)
| Date | Mar 10, 2005 (initiated Jan 14, 2005) |
| Status | Terminated |
| Reason | Some of the primary labels have the internal diameter (ID) and outer diameter (OD) numbers reversed, i.e. ID 10.9 mm and OD 8.0 mm instead of the actual ID 8.0 and OD 10.9 mm, mislabeling the size of the tracheal tube. |
| Root cause | Other |
| Action | The direct accounts were notified of the mislabeling by letter dated 1/14/05, sent via Federal Express, Next Business Day Delivery on the same date. The accounts were requested to return their inventories of the affected lot to Teleflex Medical/Hudson RCI, and to subrecall the lot from their customers. |
| Quantity | 8,990 units |
| Distribution | Nationwide |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
| K822082 | SHERIDAN/HVT,CF, UNCUFFED Sheridan Catheter Corp., Aug 10, 1982 |