TandemHeart pump is assembled into kits: TandemHeart recall
TandemHeart pump is assembled into kits: TandemHeart Kit - TS62/A17, Product: 5710-6217 - Product Usage: provides temporary extracorporeal circulatory…
Why was TandemHeart pump is assembled into kits: TandemHeart 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: S/N 00142612 00142614 00142657 00142658 00142659 00142660 00142661 00142663 00142937 00142938 00142941 00142942 00142970 00142971 00142972
- Product
- TandemHeart pump is assembled into kits: TandemHeart Kit - TS62/A17, Product: 5710-6217 - Product Usage: provides temporary extracorporeal circulatory…
- Recalling firm
- Cardiac Assist, Inc
- Quantity
- 15
- Distribution
- US Nationwide distributions.
- Recall date
- May 20, 2020
- Classification
- Class II
- Status
- Terminated
- Agency
- FDA (device)