FDAFDA · Food and drugs·Recall number Z-0085-2023
Prismaflex HF20 Set (product code 109841). For use in providing continuous fluid management and renal replacement therapies.
Published October 19, 2022 · Recall initiated: September 14, 2022
Status when published: Ongoing — openFDA updates weekly, so this field may not reflect the current status. Always confirm with the official notice.
What's the hazard
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.
What to do
Voluntary: Firm initiated · Letter
Recall details
- Manufacturer
- Baxter Healthcare Corporation
- Distributor
- US Nationwide
- Lot
- UDI 07332414089443, All Lot Codes
- Risk classification
- Class II
- Area (FDA)
- device
- Country
- United States
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