Device product

Prismaflex System, Prismaflex Control Unit

Z-1828-2020

February 06, 2020

Class II

Product summary

Firm: Baxter Healthcare Corporation
Event: Event 85007
Status: Terminated
Classification: Class II
Quantity: 4946 units
Official record key: device-enforcement:Z-1828-2020

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: 107493 GTIN 07332414073718

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.