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Recall Observatory FDA recall evidence

Device product

Infusomat Space Volumetric Pump Administration Set, Product Code 490100

Z-2137-2021

June 25, 2021

Class II

Product summary

Firm
B. Braun Medical, Inc.
Event
Event 88198
Status
Terminated
Classification
Class II
Quantity
36,144 units
Official record key
device-enforcement:Z-2137-2021

Official wording

Reason: There is a potential for the Anti-free flow clip of the administration set to be inverted which may cause unintended free flow if the user fails to follow on screen prompt to close the roller clamp prior to set removal from the pump.

Code information: Lot Number: 0061761278

Distribution pattern: Affected products were distributed to the following US states: CA, MI, OR, and UT.

Derived failure modes

  • Unknown

    reason.no_named_rule · v1.0.0

    There is a potential for the Anti-free flow clip of the administration set to be inverted which may cause unintended free flow if the user fails to follow on screen prompt to close the roller clamp prior to set removal from the pump.