Recall Z-2091-2017 ยท BTL Ventilator, Emergency, Powered (Resuscitator)
Vortran Medical Technology 1, Inc
VORTRAN Automatic Resuscitator, VARPlus; Model PTE-5002; Qty: 10 each Anesthesiology: This device is to be used by properly trained personnel to deliver emergency, short term, constant flow, pressure cycled ventilatory support.
| Date | Apr 25, 2017 (initiated Apr 20, 2017) |
| Status | Terminated |
| Reason | Vortran received a customer complaint that the spin-nut-DSS connector was assembled in the reverse direction on the oxygen tubing; making the connector unable to be screwed on due to the wrong thread direction. |
| Root cause | Process control |
| Action | Medical Device Recall letters were sent on April 20, 2017. Letters explained the reason for recall and listed the specific lots sent to each distributor along with dates, PO numbers and quantity. Vortran Medical asks that each distributor provide a list of customers who received the affected product so that they can notify them directly of the recall. |
| Quantity | 35 cases (10 each) |
| Distribution | CA, MS, FL |
| FDA record | Open on fda.gov |