| Type of Product |
Medical Device |
| TGA Recall Reference |
RC-2017-RN-00258-1 |
| Product Name/Description |
Left Double Lumen Endobronchial Tube with Parker Flex-Tip
Product Codes: WL-I-PFTDL-28, WL-I-PFTDL-32, WL-I-PFTDL-35, WL-I-PFTDL-37, WL-I-PFTDL-39 and WL-I-PFTDL-41
Batch Numbers: 608DL1325A, 608DL1325B, 608DL1325C, 608DL1325D, 608DL1325E and 608DL1325F
ARTG Number: 170268 |
| Recall Action Level |
Hospital |
| Recall Action Classification |
Class I |
| Recall Action Commencement Date |
3/03/2017 |
| Responsible Entity |
|
| Reason/Issue |
An overseas complaint has been received from a physician where the product was not functioning as intended for single lung ventilation. The physician had an experience where after full intubation isolation was not successful when the physician turned the patient on his side to begin the procedure. The physician’s supposition was that the anatomy of the patient shifted in a way that occluded the bronchial lumen and prevented continued lung isolation. The physician replaced the endobronchial tube with another product and completed the procedure. To date, there has been no patient injury or harm. |
| Recall Action |
Recall |
| Recall Action Instructions |
Device Technologies Australia (DTA) is requesting customers to immediately cease the use of affected devices. Customers are further requested to inspect and quarantine affected stock prior to their return to DTA for a replacement.
This action has been closed-out on 22/03/2018. |
| Contact Information |
03 9371 0939 - Device Technologies |