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Recall Observatory FDA recall evidence

Device product

Prismaflex System, Prismaflex Control Unit

Z-1832-2020

February 06, 2020

Class II

Product summary

Firm
Baxter Healthcare Corporation
Event
Event 85007
Status
Terminated
Classification
Class II
Quantity
626
Official record key
device-enforcement:Z-1832-2020

Official wording

Reason: Baxter is communicating safety information from the Prismaflex Operator's Manual regarding the proper use of connectors with the Prismaflex system.

Code information: Product Code:955542; GTIN 07332414124236

Distribution pattern: Distribution in US, Puerto Rico

Derived failure modes

  • Unknown

    reason.no_named_rule · v1.0.0

    Baxter is communicating safety information from the Prismaflex Operator's Manual regarding the proper use of connectors with the Prismaflex system.

Field note

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