Edwards EndoReturn Arterial Cannula recall
Edwards EndoReturn Arterial Cannula, model ER21B and ER23B Product Usage: The ThruPort EndoReturn arterial cannula kit (with or without hemostasis…
Why was Edwards EndoReturn Arterial Cannula recalled?
Edwards Lifesciences is recalling certain lots of the EndoReturn Arterial Cannula that were built with an incorrect component. This component can create a performance problem with the IntraClude IntraAortic Occlusion device.
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 ER21B Lots: 59496984, 59516933, 59516936, 59531385, 59531386 , 59543708 Model ER23B Lots: 59464327, 59484349, 59484350, 59484351, 59512146, 59513272, 59516940, 59534430, 59535739, 59541763
- Product
- Edwards EndoReturn Arterial Cannula, model ER21B and ER23B Product Usage: The ThruPort EndoReturn arterial cannula kit (with or without hemostasis…
- Recalling firm
- Edwards Lifesciences, LLC
- Quantity
- 855
- Distribution
- US Nationwide including Canada and VA sites.
- Recall date
- August 21, 2013
- Classification
- Class II
- Status
- Terminated
- Agency
- FDA (device)