Recall Z-2367-2015 ยท CBI Tube, Tracheal/Bronchial, Differential Ventilation (W/Wo Connector)
Teleflex Medical
HUDSON RCI, Sheridan Sher-I-BRONCH, Endobronchial Tube (Left sided), Sizes: 28 Fr., 35 Fr., 37 Fr., 39 Fr. and 41 Fr., Rx Only, Sterile. Intended for use in thoracic surgery, bronchospirometry, for the administration of bronchial anesthesia and other uses commonly requiring bronchial intubation.
| Date | Aug 20, 2015 (initiated Jun 1, 2015) |
| Status | Terminated |
| Reason | The double swivel connector may crack or separate on the endobronchial tube. |
| Root cause | Unknown/Undetermined by firm |
| Action | Teleflex Medical sent an Urgent Medical Device Recall Notification letter dated June 1, 2015 to their customers. The letter identified the affected product, problem and actions to be taken. Customers were directed to contact any customers who had received the product included within the scope of this recall. Customers were directed to immediately discontinue use and quarantine any products with the referenced catalog numbers and lot numbers listed in the notification. Additionally, customers were asked to return any affected product together with a completed Recall Acknowledgement Form, for c |
| Quantity | 188,195 total units |
| Distribution | Worldwide Distribution - US (nationwide) and the countries of: The Bahamas, Belgium, Argentina, Canada, China, India, Japan, South Korea, Mexico, New Zealand and Vietnam. |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
| K961977 | KENDALL SHER-I-BRONCH ENDOBROCHIAL TUBE Kendall Healthcare Products Co. Div.Of Tyco Health, Jul 31, 1996 |