Recall Z-0703-2020 ยท CBI Tube, Tracheal/Bronchial, Differential Ventilation (W/Wo Connector)
Teleflex Medical
HUDSON RCI SHERIDAN SHERI-BRONCH Endobronchial Tube REF 5-16135 - Product Usage: The Sheridan Endobronchial Tubes are intended for use in Thoracic surgery, brochospirometry, adminitration of endobronchial anesthesia and other uses commonly requiring endobronchial intubation. The Sheridan Endobronchial tube is indicated for main stem bronchus intubation and allows for selective inflation or deflati
| Date | Oct 30, 2019 |
| Status | Terminated |
| Reason | The tracheal and brochial swivel connectors are incorrectly labeled. |
| Root cause | Process control |
| Action | An Urgent Medical Device Recall letter was sent to customers via FedEx 2-day service notifying consignees of the recall. Customers are asked to immediately discontinue use and quarantine any products with the affected product code and lot number identified in the letter. Consignees are asked to complete a Recall Acknowledgement Form and fax or email it to the recalling firm. Additional questions may be directed to Customer Service at 1-866-396-2111. |
| Quantity | 53 units |
| Distribution | US Nationwide distribution in the states of CT, OK, LA, IL, GA, NY, CA, MT, MI, MA, FL. |
| 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 |