Home / Recalls / Baxter Healthcare Corporation / Z-0082-2023

Z-0082-2023 Class II Ongoing

Recalled by Baxter Healthcare Corporation — Deerfield, IL

Recall Details

Product Type
Devices
Report Date
October 19, 2022
Initiation Date
September 14, 2022
Termination Date
N/A
Voluntary/Mandated
Voluntary: Firm initiated
Product Quantity
334,932 devices

Product Description

Prismaflex M Set: M150 (product code 109990). For use in providing continuous fluid management and renal replacement therapies.

Reason for Recall

Within the current Prismaflex set IFU (instructions for use), there is a mistranslation of the Extonian (Eesti) text. The mistranslation indicates contradictory information related to the patient body weight restrictions.

Distribution Pattern

US Nationwide

Code Information

UDI 07332414090005; All Lot Codes

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