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Recall Observatory FDA recall evidence

Device product

Prismaflex ST Set: ST60 (product code 107643), ST100 (product code 107636), ST150 (product code 107640). For use in providing continuous fluid management and renal replacement therapies.

Z-0084-2023

September 14, 2022

Class II

Product summary

Firm
Baxter Healthcare Corporation
Event
Event 90841
Status
Ongoing
Classification
Class II
Quantity
1,068,560 devices
Official record key
device-enforcement:Z-0084-2023

Official wording

Reason: 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.

Code information: UDI: 07332414075682 (product code 107643), 07332414075613 (product code 107636), 07332414075651 (product code 107640); All Lot Codes

Distribution pattern: US Nationwide

Derived failure modes

  • Unknown

    reason.no_named_rule · v1.0.0

    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.