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Recall Observatory FDA recall evidence

Device product

Prismaflex HF Set: HF1000 (product code 107140), HF1400 (product code 107142). For use in providing continuous fluid management and renal replacement therapies.

Z-0083-2023

September 14, 2022

Class II

Product summary

Firm
Baxter Healthcare Corporation
Event
Event 90841
Status
Ongoing
Classification
Class II
Quantity
328,300 devices
Official record key
device-enforcement:Z-0083-2023

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 07332414069254 (product code 107140), 07332414069315 (product code 107142); 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.