Device product
Hemofiltration Standard Pack including BC 60 Plus-T 8036. Part Number: 701066990. Used in extracorporeal circulation during cardiopulmonary bypass procedures lasting 6 hours or less.
Z-0490-2018
Product summary
- Firm
- Maquet
- Event
- Event 78765
- Status
- Terminated
- Classification
- Class II
- Quantity
- 55 units
- Official record key
device-enforcement:Z-0490-2018
Official wording
Reason: 55 kits were distributed after their expiration date of September 2015.
Code information: Lot/batch number: 3000001571 UDI code: 607567206489
Distribution pattern: Distributed to the states of NM, CA, and IL.
Derived failure modes
-
Unknown
55 kits were distributed after their expiration date of September 2015.