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Recall Observatory FDA recall evidence

Device product

Maquet Getinge-BEQ-TOP 38900 ECC PACK Material: 701056368

Z-1547-2019

April 18, 2019

Class II

Product summary

Firm
Maquet Cardiovascular, LLC
Event
Event 82703
Status
Terminated
Classification
Class II
Quantity
N/A
Official record key
device-enforcement:Z-1547-2019

Official wording

Reason: Custom Tubing Sets for Extracorporeal Circulation (ECC)-During sterilization, the closed stopcock/non-vented cap configuration may prevent the flow of humidity/ethylene oxide gas into the fluid-path between the closed port and the non-vented cap therefore the Sterility Assurance Level (SAL) of the stopcock ports cannot be assured

Code information: Batch Numbers: 3000041396 3000044053 3000047317 3000050887 3000058131 3000060487 3000060723 3000062458 3000064724 3000071815 3000071817

Distribution pattern: Nationwide

Derived failure modes

  • Sterility assurance

    reason.sterility_assurance · v1.0.0

    Sterility Assurance Level (SAL) of the stopcock ports cannot be assured