Prismaflex HF20 Set (product code 109841). For use in providing continuous fluid management and renal replacement therapies.
Reported: October 19, 2022 Initiated: September 14, 2022 #Z-0085-2023
Product Description
Prismaflex HF20 Set (product code 109841). For use in providing continuous fluid management and renal replacement therapies.
Reason for Recall
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.
Details
- Recalling Firm
- Baxter Healthcare Corporation
- Units Affected
- 29,764 devices
- Distribution
- US Nationwide
- Location
- Deerfield, IL
Frequently Asked Questions
What product was recalled? ▼
Prismaflex HF20 Set (product code 109841). For use in providing continuous fluid management and renal replacement therapies.. Recalled by Baxter Healthcare Corporation. Units affected: 29,764 devices.
Why was this product recalled? ▼
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.
Which agency issued this recall? ▼
This recall was issued by the FDA Devices on October 19, 2022. Severity: Moderate. Recall number: Z-0085-2023.
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