FDAFDA · Food and drugs·Recall number Z-2092-2017
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.
Published May 24, 2017 · Recall initiated: April 20, 2017
Status when published: Terminated — openFDA updates weekly, so this field may not reflect the current status. Always confirm with the official notice.
What's the hazard
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.
What to do
Voluntary: Firm initiated · Letter
Recall details
- Manufacturer
- Vortran Medical Technology 1, Inc
- Distributor
- CA, MS, FL
- Lot
- Model PCE 5012; Lot number/ expiry date: 1419 PCE , 2019-03-12; 1434 PCE, 2019-06-04.
- Risk classification
- Class II
- Area (FDA)
- device
- Country
- United States
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