Baxter Healthcare Corporation: 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.

Agency Publication Date: October 12, 2022

Affected Products

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

UDI: 07332414064549 (product code 106696), 07332414064556 (product code 106697); All lot codes

Lot Numbers:

106696

106697

codes

Product: Prismaflex M Set: M150 (product code 109990). For use in providing continuous fluid management and renal replacement therapies.

UDI 07332414090005; All Lot Codes

Lot Numbers:

Codes

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

UDI 07332414069254 (product code 107140), 07332414069315 (product code 107142); All Lot Codes

Lot Numbers:

107140

107142

Codes

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.

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

Lot Numbers:

107643

107636

107640

Codes

Product: Prismaflex HF20 Set (product code 109841). For use in providing continuous fluid management and renal replacement therapies.

UDI 07332414089443, All Lot Codes

Lot Numbers:

Codes

Additional Information

Agency: Food and Drug Administration (FDA)

Event ID: 90841

Status: Active

Manufacturer: Baxter Healthcare Corporation

Manufactured In: United States

Units Affected: 5 products (524,376 devices; 334,932 devices; 328,300 devices; 1,068,560 devices; 29,764 devices)

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AI-Enhanced Content: The summary, action steps, and risk assessment on this page were generated by AI from official government recall data to improve readability. This is not legal or medical advice. Always refer to the official agency sources below for authoritative information.

Sources: FDA iRES · Raw API Response

openFDA Disclaimer: This recall information is sourced from the openFDA API. Do not rely on openFDA to make decisions regarding medical care. While we make every effort to ensure that data is accurate, you should assume all results are unvalidated. Refer to the openFDA terms of service for more information.

Affected Products

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

UDI: 07332414064549 (product code 106696), 07332414064556 (product code 106697); All lot codes

Lot Numbers:

106696

106697

codes

Product: Prismaflex M Set: M150 (product code 109990). For use in providing continuous fluid management and renal replacement therapies.

UDI 07332414090005; All Lot Codes

Lot Numbers:

Codes

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

UDI 07332414069254 (product code 107140), 07332414069315 (product code 107142); All Lot Codes

Lot Numbers:

107140

107142

Codes

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.

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

Lot Numbers:

107643

107636

107640

Codes

Product: Prismaflex HF20 Set (product code 109841). For use in providing continuous fluid management and renal replacement therapies.

UDI 07332414089443, All Lot Codes

Lot Numbers:

Codes