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Recall Observatory FDA recall evidence

Device product

Prismaflex Control Unit

Z-2066-2020

April 07, 2020

Class II

Product summary

Firm
Baxter Healthcare Corporation
Event
Event 85405
Status
Terminated
Classification
Class II
Quantity
5 devices US territories
Official record key
device-enforcement:Z-2066-2020

Official wording

Reason: Prismaflex product code 114870 does not have FDA regulatory clearance and was inadvertently distributed.

Code information: Product Code: 114870; Lot Number: PA18198, PA18199, PA18238, PA22556, PA22558.

Distribution pattern: Distribution only to Puerto Rico and Guam

Derived failure modes

  • Unknown

    reason.no_named_rule · v1.0.0

    Prismaflex product code 114870 does not have FDA regulatory clearance and was inadvertently distributed.