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Recall Observatory FDA recall evidence

Device product

Alaris Pump Module model 8100

Z-2700-2017

June 12, 2017

Class II

Product summary

Firm
CareFusion 303, Inc.
Event
Event 77279
Status
Terminated
Classification
Class II
Quantity
35,940 units
Official record key
device-enforcement:Z-2700-2017

Official wording

Reason: There is a potential risk that could cause unintended flow in the older, centered sear door latch design in the Alaris Pump module model 8100.

Code information: Notification will be distributed to all Alaris Pumps customers with pumps manufactured between June 2002 through June 2004.

Distribution pattern: US and Canada

Derived failure modes

  • Unknown

    reason.no_named_rule · v1.0.0

    There is a potential risk that could cause unintended flow in the older, centered sear door latch design in the Alaris Pump module model 8100.