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Recall Observatory FDA recall evidence

Device product

Maquet Cardiopulmonary Bypass Custom Tubing kit BEQ-TOP 5909 14 Pack QPID, Part Number 701064992

Z-2106-2018

March 11, 2016

Class III

Product summary

Firm
Datascope Corporation
Event
Event 80086
Status
Terminated
Classification
Class III
Quantity
19 total kits
Official record key
device-enforcement:Z-2106-2018

Official wording

Reason: There is a potential problem with the cuvette where failure of the cuvette would cause an error message on the monitor display of H/S DISCONNECT AT CUVETTE.

Code information: Batch Number 3000018640, UDI Code 10607567205373; Batch Number 3000020516, UDI Code 10607567205373

Distribution pattern: The products were distributed to the following US states: AL, OR, and TX.

Derived failure modes

  • Unknown

    reason.no_named_rule · v1.0.0

    There is a potential problem with the cuvette where failure of the cuvette would cause an error message on the monitor display of H/S DISCONNECT AT CUVETTE.