Edwards Lifesciences Fem-Flex Femoral Arterial Cannula recall
Edwards Lifesciences Fem-Flex Femoral Arterial Cannula with Duraflo Coating, DIITFA02225, Sterile, RX only For Single Use Only, Product Usage: Edwards…
Why was Edwards Lifesciences Fem-Flex Femoral Arterial Cannula recalled?
Edwards Lifesciences is recalling two lots of Duraflo Cannulas due to reported complaints involving cracks in the t-connector of the devices which were confirmed during product evaluation.
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?
Lot number 59388992 expiry 1/1/16
- Product
- Edwards Lifesciences Fem-Flex Femoral Arterial Cannula with Duraflo Coating, DIITFA02225, Sterile, RX only For Single Use Only, Product Usage: Edwards…
- Recalling firm
- Edwards Lifesciences, LLC
- Quantity
- 80 units
- Distribution
- Nationwide Distribution.
- Recall date
- November 13, 2013
- Classification
- Class II
- Status
- Terminated
- Agency
- FDA (device)