Z-2092-2017 Class II Terminated
FDA device recall Z-2092-2017 was initiated by Vortran Medical Technology 1, Inc on April 20, 2017 and is designated Class II. 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 … The recall status is terminated (terminated October 17, 2017). Affected quantity: 14 cases (10 each).
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
- 14 cases (10 each)
Product Description
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.
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 PCE 5012; Lot number/ expiry date: 1419 PCE , 2019-03-12; 1434 PCE, 2019-06-04.