VORTRAN Automatic Resuscitator recall
VORTRAN Automatic Resuscitator, VARPlus with Extension Kit; Model PCE-5012; Qty: 10 each. Anesthesiology: This device is to be used by properly…
Why was VORTRAN Automatic Resuscitator 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.
What should I do if I have this product?
Review the official FDA enforcement record for current instructions.
What to do with a recalled product: refunds, receipts, safe disposal and how to report a problem.
Is my product affected?
Compare the item in your hand with every identifier below from the official FDA record. Only products that match the listed product and lot, UPC or model codes are part of this recall.
Which lot codes, UPCs or models are affected?
Model PCE 5012; Lot number/ expiry date: 1419 PCE , 2019-03-12; 1434 PCE, 2019-06-04.
- Product
- VORTRAN Automatic Resuscitator, VARPlus with Extension Kit; Model PCE-5012; Qty: 10 each. Anesthesiology: This device is to be used by properly…
- Recalling firm
- Vortran Medical Technology 1, Inc
- Quantity
- 14 cases (10 each)
- Distribution
- CA, MS, FL
- Recall date
- May 24, 2017
- Classification
- Class II
- Status
- Terminated
- Agency
- FDA (device)