TandemHeart pump is assembled into kits: ProtekDuo Kit recall
TandemHeart pump is assembled into kits: ProtekDuo Kit - DL3, Product: 5720-3118 - Product Usage: provides temporary extracorporeal circulatory system…
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: 00142562 00142563 00142564 00142565 00142566 00142567 00142568 00142583 00142585 00142587 00142588 00142589 00142602 00142603 00142604 00142607 00142610 00142611 00142653 00142655 00142684 00142685 00142686 00142687 00142688 00142689 00142690 00142701 00142702 00142703 00142704 00142705 00142706 00142927 00142928 00142953 00142954 00142955 00142956 00142957 00142958 00142959 00142962 00142964 00142966 00142967
- Product
- TandemHeart pump is assembled into kits: ProtekDuo Kit - DL3, Product: 5720-3118 - Product Usage: provides temporary extracorporeal circulatory system…
- Recalling firm
- Cardiac Assist, Inc
- Quantity
- 46
- Distribution
- US Nationwide distributions.
- Recall date
- May 20, 2020
- Classification
- Class II
- Status
- Terminated
- Agency
- FDA (device)