VORTRAN Automatic Resuscitator recall
VORTRAN Automatic Resuscitator, VARPlus; Model PTE-5002; Qty: 10 each Anesthesiology: This device is to be used by properly trained personnel to…
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 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;
- Product
- VORTRAN Automatic Resuscitator, VARPlus; Model PTE-5002; Qty: 10 each Anesthesiology: This device is to be used by properly trained personnel to…
- Recalling firm
- Vortran Medical Technology 1, Inc
- Quantity
- 35 cases (10 each)
- Distribution
- CA, MS, FL
- Recall date
- May 24, 2017
- Classification
- Class II
- Status
- Terminated
- Agency
- FDA (device)