TandemHeart pump is assembled into kits: ProtekDuo Kit recall
TandemHeart pump is assembled into kits: ProtekDuo Kit - DL29, Product: 5720-2916 - Product Usage: provides temporary extracorporeal circulatory…
Why was TandemHeart pump is assembled into kits: ProtekDuo 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: 00142569 00142570 00142571 00142572 00142573 00142574 00142575 00142576 00142592 00142593 00142594 00142595 00142597 00142598 00142600 00142601 00142664 00142665 00142666 00142668 00142669 00142670 00142671 00142672 00142673 00142674 00142692 00142693 00142694 00142696 00142697 00142698 00142699 00142926 00142930 00142933 00142936 00142934
- Product
- TandemHeart pump is assembled into kits: ProtekDuo Kit - DL29, Product: 5720-2916 - Product Usage: provides temporary extracorporeal circulatory…
- Recalling firm
- Cardiac Assist, Inc
- Quantity
- 38
- Distribution
- US Nationwide distributions.
- Recall date
- May 20, 2020
- Classification
- Class II
- Status
- Terminated
- Agency
- FDA (device)