Recall Z-0680-05 ยท CBI Tube, Tracheal/Bronchial, Differential Ventilation (W/Wo Connector)
Teleflex Medical
Sheridan Sher-I-Bronch Left Endobronchial Tube; an Rx, sterile, sinlge use endobronchial tube with modified tip for left bronchial intubation, 37 Fr.; Hudson Respiratory Care Inc., Temecula, CA 92589-9020, Manufactured in Mexico; sold under the following catalog numbers: a) catalog number (REF) V5-16037: Novaplus Sterile Sher-I-Bronch Endobronchial Tube for Left Bronchial Intubation, 37 Fr., Novat
| Date | Apr 6, 2005 (initiated Feb 23, 2005) |
| Status | Terminated |
| Reason | The distal end of the tube may be printed incorrectly, with catalog numbers V5-16037 and 5-16037 stating 'Bronchial - Right' instead of 'Bronchial - Left', and catalog number 5-16137 stating 'Bronchial - Left' instead of 'Bronchial - Right'. |
| Root cause | Other |
| Action | Customers were notified via Federal Express, Next Business Day Delivery, on February 23, 2005. The accounts were informed of the mislabeling and were instructed to inspect the product lots for any incorrectly printed devices, comparing the writing on the sleeve of the blue bronchial tube with the package label which is correct, and to return all identified affected product to Teleflex Medical, Hudson RCI. |
| Distribution | Nationwide and internationally to Argentina, Canada, Chile, China, Costa Rica, Hong Kong, Korea, the Netherlands, South Africa and Vietnam. |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
| K851856 | TRACHEAL/BRONCHIAL DIFFERENTIAL VENTILATION TUBE Sheridan Catheter Corp., May 23, 1985 |