Recall Z-2092-2017
Vortran Medical Technology 1, Inc · initiated April 20, 2017
Class II – products that might cause a temporary health problem or pose a slight threat of a serious nature
Product
VORTRAN Automatic Resuscitator, VARPlus with Extension Kit; Model PCE-5012; 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.
Codes / lots: Model PCE 5012; Lot number/ expiry date: 1419 PCE , 2019-03-12; 1434 PCE, 2019-06-04.
Reason for recall
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.
FDA-determined cause: Process control
Action taken
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.
Details
- Recall number
- Z-2092-2017
- Initiated
- April 20, 2017
- Posted by FDA
- April 25, 2017
- Terminated
- October 17, 2017
- Product code
- BTL – Ventilator, Emergency, Powered (Resuscitator)
- Quantity
- 14 cases (10 each)
- Distribution
- CA, MS, FL
- Recalling firm
- Vortran Medical Technology 1, Inc, Sacramento, CA
Other products in the same recall event
| Recall | Product | Initiated |
|---|---|---|
| Z-2091-2017 Class II | VORTRAN Automatic Resuscitator, VARPlus; Model PTE-5002; Qty: 10 each Anesthesiology:…Vortran received a customer complaint that the spin-nut-DSS connector was assembled in the reverse direction… | 04/20/2017Terminated |