Recall Z-1399-2017 ยท CBI Tube, Tracheal/Bronchial, Differential Ventilation (W/Wo Connector)
Parker Medical
Parker Left Double Lumen Endobronchial Tube with Parker Flex-Tip (Parker Endo-Bronch with Flex Tip). Model Numbers: H-PFTDL-28-1, H-PFTDL-32-1, H-PFTDL-35-1, H-PFTDL-37-1, H-PFTDL-39-1, H-PFTDL-41-1. The product is an endotracheal tube with a double lumen for single lung isolation allowing for ventilation of one lung during a surgical procedure. Endotracheal tubes are used for intubating patients
| Date | Mar 3, 2017 (initiated Dec 16, 2016) |
| Status | Terminated |
| Reason | The product was not functioning as intended. The ventilation to the patient was not disrupted, but the single lung isolation and ventilation did not function as intended. |
| Root cause | Under Investigation by firm |
| Action | Parker Medical notified consignees via telephone on December 16, 2016. Consignees were instructed to segregate affected products for immediate pick up. For questions regarding this recall call 239-307-6064. |
| Quantity | 1,060 units |
| Distribution | Nationwide Distribution to CO, FL, IN, SC and TX. One VA consignee. |
| FDA record | Open on fda.gov |