Edwards Lifesciences Duraflo coated Femoral Cannula. recall: Sterility Concern
Edwards Lifesciences Duraflo coated Femoral Cannula. Product Usage: The cannulae are intended for use in situations which require rapid femoral venous…
Why was Edwards Lifesciences Duraflo coated Femoral Cannula. recalled?
Two unsealed pouches were found at an Edwards' distribution location in Japan. Incorrectly sealed pouches may result in a sterility barrier breach.
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 DIIFEMII018A, Lot 59337174
- Product
- Edwards Lifesciences Duraflo coated Femoral Cannula. Product Usage: The cannulae are intended for use in situations which require rapid femoral venous…
- Recalling firm
- Edwards Lifesciences, LLC
- Quantity
- 379 units
- Distribution
- USA Nationwide Distribution including the states of: FL, MA, MI, NY, PA, TX.
- Recall date
- April 24, 2013
- Classification
- Class II
- Status
- Terminated
- Agency
- FDA (device)