Vortran Medical Technology 1, Inc: 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.

Agency Publication Date: April 25, 2017

Affected Products

Product: 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.

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;

Lot Numbers:

number

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.

Model PCE 5012; Lot number/ expiry date: 1419 PCE , 2019-03-12; 1434 PCE, 2019-06-04.

Lot Numbers:

number

Additional Information

Agency: Food and Drug Administration (FDA)

Event ID: 77072

Status: Resolved

Manufacturer: Vortran Medical Technology 1, Inc

Manufactured In: United States

Units Affected: 2 products (35 cases (10 each); 14 cases (10 each))

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Sources: FDA iRES · Raw API Response

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Affected Products

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;

Lot Numbers:

number

Model PCE 5012; Lot number/ expiry date: 1419 PCE , 2019-03-12; 1434 PCE, 2019-06-04.

Lot Numbers:

number