CLASS II Device recall · Reported 24 May 2017 · FDA Enforcement Report
Vortran Automatic Resuscitator, VARPlus recalled
Vortran Medical Technology 1 is recalling Vortran Automatic Resuscitator, VARPlus, distributed in California, Florida, Mississippi. The recall was initiated on 20 Apr 2017 and the FDA has classified it as Class II.
Check your package
Stop using the device if the notice says to, and contact the manufacturer or your healthcare provider for the correction or replacement.
Recall details
- Recall number
- Z-2091-2017
- FDA event ID
- 77072
- Recalling firm
- Vortran Medical Technology 1, Sacramento, CA
- Classification
- Class II
- Status
- Terminated
- Recall initiated
- 20 Apr 2017
- FDA classified
- 13 May 2017
- Reported
- 24 May 2017
- Type
- Voluntary: Firm initiated
- Customers notified by
- Letter
- Reason category
- Other Reasons
- Device type
- CPAP & Ventilators
Timeline
| 20 Apr 2017 | Recall initiated by company | |
| 13 May 2017 | Classified by FDA | +23 days |
| 24 May 2017 | Published in enforcement report | +11 days |
Companies usually start a recall weeks before the FDA classifies and publishes it; the gap above is that lag.
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.
Product as listed by the FDA
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.
Where it was distributed
CA, MS, FL
Questions about this recall
Is Vortran Automatic Resuscitator, VARPlus recalled?
Yes. Vortran Medical Technology 1 recalled Vortran Automatic Resuscitator, VARPlus on 20 Apr 2017. The recall is Class II and its status is Terminated. Recall number Z-2091-2017.
Why was it recalled?
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.
Which lots are affected?
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;
Where was it sold?
CA, MS, FL
What should I do if I have it?
Stop using the device if the notice says to, and contact the manufacturer or your healthcare provider for the correction or replacement.
What does Class II mean?
Class II means the product may cause temporary or medically reversible health problems, or the probability of serious harm is remote.
Read the official FDA notice · Source record retrieved 21 Sep 2026. The FDA describes openFDA data as unvalidated; the official notice takes precedence. This page reports the record and gives no medical advice.
More recalls from Vortran Medical Technology 1
All 2| Reported | Class | Recall | Company | Reason | Where |
|---|---|---|---|---|---|
| Device | CLASS II | Vortran Automatic Resuscitator, VARPlus with Extension Kit recalled | Vortran Medical Technology 1 | Other | CA, FL, MS |
Other CPAP & Ventilators recalls
All 552| Reported | Class | Recall | Company | Reason | Where |
|---|---|---|---|---|---|
| Device | CLASS II | Medline Hudson Rci, Dbd-circuit,Vent,Inspiratory,Heated,Neo recalled | Medline Industries | Device Malfunction | Nationwide |
| Device | CLASS II | Getinge Y Sensor Module, Servo-u, Servo-n recalled | Maquet Critical Care AB | Device Malfunction | Nationwide |
| Device | CLASS II | Biofire Respiratory Panel 1 (RP2.1) recalled by BioFire Diagnostics | BioFire Diagnostics | Other | Nationwide |
| Device | CLASS I | Astral 100/150 Resmed Astral 100/50 is a ventilator system recalled | ResMed | Packaging Defects | Nationwide |
| Device | CLASS I | Breathing circuit set, coaxial recalled by Hamilton Medical AG | Hamilton Medical AG | Device Malfunction | Nationwide |