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Recall Observatory FDA recall evidence

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

May 22, 2017

Class II

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

    reason.no_named_rule · v1.0.0

    55 kits were distributed after their expiration date of September 2015.