Home / Recalls / Baxter Healthcare Corporation / Z-0085-2023

Z-0085-2023 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
29,764 devices

Product Description

Prismaflex HF20 Set (product code 109841). 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 07332414089443, All Lot Codes

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