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.
Class I - DangerousWhat Should You Do?
- Check if you have this product: Model PCE 5012; Lot number/ expiry date: 1419 PCE , 2019-03-12; 1434 PCE, 2019-06-04.
- Do not eat it: Even if it looks and smells fine, do not consume this product.
- Throw it away or return it: You can return the product to the store for a full refund.
- Seek medical attention if needed: If you've consumed this product and feel unwell, contact your doctor immediately.
- Report problems: Report any issues to the FDA's Safety Reporting Portal.
⚠️ Emergency: If you experience severe symptoms after consuming this product, call 911 or Poison Control at 1-800-222-1222.
Recall Details
- Company:
- Vortran Medical Technology 1, Inc
- 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.
- Classification:
- Class I - Dangerous
Dangerous or defective products that predictably could cause serious health problems or death.
- Status:
- terminated
Product Information
Full 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.
Product Codes/Lot Numbers:
Model PCE 5012; Lot number/ expiry date: 1419 PCE , 2019-03-12; 1434 PCE, 2019-06-04.
Distribution:
Distributed in: CA, MS, FL
Official Source
Always verify recall information with the official FDA source:
View on FDA.govFDA Recall Number: Z-2092-2017
Related Recalls
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.
Vortran Medical Technology 1
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.