Home / Recalls / Vortran Medical Technology 1, Inc / Z-2091-2017

Z-2091-2017 Class II Terminated

Recalled by Vortran Medical Technology 1, Inc — Sacramento, CA

Recall Details

Product Type: Devices
Report Date: May 24, 2017
Initiation Date: April 20, 2017
Termination Date: October 17, 2017
Voluntary/Mandated: Voluntary: Firm initiated
Product Quantity: 35 cases (10 each)

Product Description

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.

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.

Distribution Pattern

CA, MS, FL

Code Information

Model PTE 5002; Lot number/ expiry date: 1424 PTE, 2019-04-24; 1428 PTE , 2019-05-06; 1436 PTE, , 2019-06-16; 1440 PTE , 2019-06-30;