TandemHeart Pump Kit recall
TandemHeart Pump Kit, Product: 5120-0000 - Product Usage: provides temporary extracorporeal circulatory system support with the unique ability to…
Why was TandemHeart Pump Kit recalled?
Failure to prime due to an assembly error
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?
Serial Numbers: 00142577 00142578 00142579 00142656 00142675 00142944 00142946 00142947 00142960 00142961
- Product
- TandemHeart Pump Kit, Product: 5120-0000 - Product Usage: provides temporary extracorporeal circulatory system support with the unique ability to…
- Recalling firm
- Cardiac Assist, Inc
- Quantity
- 10
- Distribution
- US Nationwide distributions.
- Recall date
- May 20, 2020
- Classification
- Class II
- Status
- Terminated
- Agency
- FDA (device)