Food, drugs, devices › Baxter Healthcare Corporation
Device recall: Prismaflex M Set: M60 (product code 106696), M100 (product code 106697). For use in providing continuous fluid managemen
FDA enforcement event 90841 is a device recall by Baxter Healthcare Corporation of Deerfield, IL, initiated 14 Sep 2022 and classified Class II, with 5 product records.
FDA defines Class II as a situation in which use of or exposure to a violative product may cause temporary or medically reversible adverse health consequences or where the probability of serious adverse health consequences is remote. 88% of the 839 device enforcement events initiated in 2022 carry the same class.
Status: Ongoing. Initiation: voluntary: firm initiated. Baxter Healthcare Corporation has 193 enforcement events on this register, with a median of 1 product record per event.
Recall classification reflects the relative degree of health hazard. Text in quotation marks is FDA's. openFDA export dated 28 Sep 2026.
Recalling firm
Baxter Healthcare Corporation, Deerfield, IL.
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."
Distribution
"US Nationwide"
Product records
| Recall number | Product | Quantity | Class | Status | Report date |
|---|---|---|---|---|---|
| Z-0081-2023 | Prismaflex M Set: M60 (product code 106696), M100 (product code 106697). For use in providing continuous fluid management and renal replacement therapies. | 524,376 devices | Class II | Ongoing | 19 Oct 2022 |
| Z-0082-2023 | Prismaflex M Set: M150 (product code 109990). For use in providing continuous fluid management and renal replacement therapies. | 334,932 devices | Class II | Ongoing | 19 Oct 2022 |
| Z-0083-2023 | Prismaflex HF Set: HF1000 (product code 107140), HF1400 (product code 107142). For use in providing continuous fluid management and renal replacement therapies. | 328,300 devices | Class II | Ongoing | 19 Oct 2022 |
| Z-0084-2023 | 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. | 1,068,560 devices | Class II | Ongoing | 19 Oct 2022 |
| Z-0085-2023 | Prismaflex HF20 Set (product code 109841). For use in providing continuous fluid management and renal replacement therapies. | 29,764 devices | Class II | Ongoing | 19 Oct 2022 |
Context
Other enforcement events for Baxter Healthcare Corporation
All 193 events for Baxter Healthcare Corporation
Questions and answers
Why was this device recalled?
FDA's record gives the reason for recall as: "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 does Class II mean?
FDA classifies recalls by relative degree of health hazard. Class II is a situation in which use of or exposure to a violative product may cause temporary or medically reversible adverse health consequences or where the probability of serious adverse health consequences is remote.
Where was the product distributed?
FDA's distribution pattern field reads: "US Nationwide"
Is the recall still ongoing?
FDA lists the status as Ongoing. "Terminated" means FDA has determined that all reasonable efforts to remove or correct the product have been made.
Where does this data come from?
openFDA enforcement reports (food, drug and device), CC0, export dated 28 Sep 2026. Text in quotation marks is FDA's. The FDA enforcement report linked above is authoritative.
Provenance
Source: openFDA device enforcement reports (CC0), export dated 28 Sep 2026; records grouped by FDA event number. The class shown for the event is the most severe class among its records. Errors in processing are corrected at the next build; see corrections.