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Baxter Healthcare Corporation Recall 90841

Description: Prismaflex HF20 Set (product code 109841). For use in providing continuous fluid management and renal replacement therapies.

Baxter Healthcare Corporation Recall 90841 Information

StatusOngoing
Mandated?Voluntary: Firm initiated
Recall NumberZ-0085-2023
Event ID90841
Event DescriptionPrismaflex HF20 Set (product code 109841). For use in providing continuous fluid management and renal replacement therapies.
Product TypeDevices
DistributionUS Nationwide
Quantity29,764 devices
Recall ReasonWithin 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.
Device Classification20221019
Device Code InfoUDI 07332414089443, All Lot Codes
Center Classification Date20221012
Recall Initiation Date20220914
Recalling FirmBaxter Healthcare Corporation
Initial Notification Letter
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