Recall Z-2243-2016 ยท BTR Tube, Tracheal (W/Wo Connector)
Parker Medical
Parker Trach-Vac Endotracheal Tubes. Tyvek pouches, 10 per box. Product Usage: The product is an endotracheal tube with sub-glottic suction channel to remove secretions. It is used for intubating patients and used with a ventilator to provide oxygen or anesthetic agents to the patient.
| Date | Jul 19, 2016 (initiated Jun 2, 2016) |
| Status | Terminated |
| Reason | Parker Medical announces a voluntary field action for the Parker Trach-Vac Endotracheal Tubes - (Endotracheal tube,with Parker Flex-Tip,Sub-Glottic Suction, High Volume low Pressure) due to tube kinking during use. |
| Root cause | Nonconforming Material/Component |
| Action | Customers were notified on June 2, 2016 that a recall was initiated via telephone. The information communicated identified the affected product, problem and actions to be taken. Customers were instructed to segregate the affected product for immediate pick-up. A Sales Representatives went to each hospital and retrieved all unused product. |
| Quantity | 5,500 units |
| Distribution | US Nationwide Distribution in the states of KY, MO, FL, TN, and TX. |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
| K110269 | WELL LEAD ENDOTRACHEAL TUBE WITH EVACUATION LUMEN-ORAL Well Lead Medical Co., Ltd., Aug 26, 2011 |