Z-1948-2020 Class II Terminated
FDA device recall Z-1948-2020 was initiated by Cardiac Assist, Inc on March 6, 2020 and is designated Class II. Reason for recall: Failure to prime due to an assembly error The recall status is terminated (terminated November 20, 2020). Affected quantity: 10.
Recall Details
- Product Type
- Devices
- Report Date
- May 20, 2020
- Initiation Date
- March 6, 2020
- Termination Date
- November 20, 2020
- Voluntary/Mandated
- Voluntary: Firm initiated
- Product Quantity
- 10
Product Description
TandemHeart Pump Kit, Product: 5120-0000 - Product Usage: provides temporary extracorporeal circulatory system support with the unique ability to locally deliver an anticoagulant through the infusion system.
Reason for Recall
Failure to prime due to an assembly error
Distribution Pattern
US Nationwide distributions.
Code Information
Serial Numbers: 00142577 00142578 00142579 00142656 00142675 00142944 00142946 00142947 00142960 00142961