Home / Recalls / Baxter Healthcare Corporation / Z-2066-2020

Z-2066-2020 Class II Terminated

Recalled by Baxter Healthcare Corporation — Deerfield, IL

Recall Details

Product Type
Devices
Report Date
May 27, 2020
Initiation Date
April 7, 2020
Termination Date
November 9, 2021
Voluntary/Mandated
Voluntary: Firm initiated
Product Quantity
5 devices US territories

Product Description

Prismaflex Control Unit

Reason for Recall

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

Distribution Pattern

Distribution only to Puerto Rico and Guam

Code Information

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

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