Recall Z-2092-2017— Vortran Medical Technology 1, Inc
Class II · Terminated
Class II FDA medical device recall by Vortran Medical Technology 1, Inc, initiated 2017-04-20, terminated 2017-10-17. It names 3 FDA 510(k) clearances: K041473, K001430, K973975. 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.. Reason: 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..
- Recalling firm
- Vortran Medical Technology 1, Inc
- Classification
- Class II
- Status
- Terminated
- Initiated
- 2017-04-20
- Terminated
- 2017-10-17
- Firm location
- Sacramento, CA, United States
510(k) clearances named in this recall
3 on FDA's record- K041473 — VAR-PLUS (VORTRAN AUTOMATIC RESUSCITATOR), MODEL PCM
- K001430 — RESPIRTECH PRO-O2C, MODEL 2200 AND RESPIRTECH PRO, MODEL 2000
- K973975 — RESPIRTECHPRO
K-numbers as listed on FDA's Recall Enterprise System record for this event (openFDA device/recall k_numbers). The recall may also cover devices cleared under other submissions not named here.
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.
Data sourced from openFDA. This site is unofficial and independent of the FDA.