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Recall Observatory FDA recall evidence

Device product

Prismaflex M Set: M60 (product code 106696), M100 (product code 106697). For use in providing continuous fluid management and renal replacement therapies.

Z-0081-2023

September 14, 2022

Class II

Product summary

Firm
Baxter Healthcare Corporation
Event
Event 90841
Status
Ongoing
Classification
Class II
Quantity
524,376 devices
Official record key
device-enforcement:Z-0081-2023

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: 07332414064549 (product code 106696), 07332414064556 (product code 106697); 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.