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PrismaSATE 105351Recalls & reported problems

Baxter International Inc. · The product is a sterile dialysis solution intended for treatment of acute kidney disease (renal failure) using Continuous Renal Replacement Therapies, such as continuous hemodialysis and hemodiafiltration aimed at normalizing the composition of the blood. The product may also be used in case of drug poisoning with dialyzable or filterable substances. · Class 2

All models of PrismaSATE (2)

Data updated Oct 18, 2026 from official FDA records · Editorial policy

Adverse event reports
0
Deaths reported
0
Injuries reported
0
Recalls naming it
1

Summary

No MAUDE adverse event reports in our data reference this device identifier directly.

1 FDA recall record name this device's identifier.

Reports come from manufacturers, hospitals and patients and are not verified by the FDA. A report does not prove the device caused the event, and counts can't be used to compare devices or estimate failure rates. What reports can and can't tell you · How this data works · Data updated Oct 18, 2026.

Recalls naming this device

  1. May 23, 2016Class IITerminated

    Presence of leaks near top of the PrismaSate bags

    Z-2049-2016 · Root cause: Other · Recall details · FDA record ↗

Other DIALYSATE CONCENTRATE FOR HEMODIALYSIS (LIQUID OR POWDER) devices

All DIALYSATE CONCENTRATE FOR HEMODIALYSIS (LIQUID OR POWDER) devices →

Sources and updates

How reports and recalls are matched · Editorial policy · Report an error on this page