FDA Devices recall · Reported April 11, 2018
Prismaflex Control Unit. Dialyzer, high permeability with or without sealed dialysate system. Continuous Renal Replacement Therapy (CRRT) for patients weighing 20 kilograms or more with acute renal failure and/or fluid overload. *Therapeutic Plasma Exchange (TPE) therapy for patients weighing 20 kilograms or more with diseases where removal of plasma components is indicated.
Firm has received reports of device operators failing to adhere to instructions for use pertaining to the safe unloading of disposable sets from the Prismaflex Control Unit. Addit…
Baxter Healthcare Corporation recalled Prismaflex Control Unit. Dialyzer, high permeability with or without sealed dialysate sy… - a moderate-severity action.
Prismaflex Control Unit. Dialyzer, high permeability with or without sealed dialysate sy… was recalled by Baxter Healthcare Corporation in April 11, 2018. Reason: Firm has received reports of device operators failing to adhere to instructions for use pertaining to the saf…. Check the official notice for the remedy. Verify recall #Z-1280-2018 with the FDA Devices before acting.
The recall
Baxter Healthcare Corporation issued this moderate-severity FDA Devices recall-Firm has received reports of device operators failing to adhere to instructions for use pertaining to the saf….
- Moderate
- severity level
- 3K units
- affected scope
- Class II
- classification
- April 11, 2018
- reported
Sourced from official FDA Devices enforcement records. Verify recall #Z-1280-2018 with the agency before acting. Full product description, hazard, remedy, and related recalls are below.
Recall Insight
This recall's affected scope, documented in the Recall Profile below, stays within a single-region or limited-distribution footprint. Distribution scope (see Distribution below) directly affects the consumer exposure window and determines whether a recall remains regional or escalates into a nationwide advisory.
Within the same product category the archive holds 6 closely related recalls, 6 from FDA Devices - clustering in a narrow category often points to a systemic quality-control or supplier issue rather than a one-off defect. Always verify the recall number against the official agency record before acting.
Medical Devices recalls over time
Where this recall sits in its category - 41,021 medical devices recalls on record
Of 88,244 recalls with an agency hazard classification, 19,068 are high severity, 64,652 moderate, and 4,524 low. A further 16,179 CPSC/NHTSA recalls have no agency class and are excluded from this split. This recall is classified moderate severity.
Counts reflect market size and reporting activity, not inherent danger, we do not rank products by risk from raw recall volume.
Product description
Prismaflex Control Unit. Dialyzer, high permeability with or without sealed dialysate system. Continuous Renal Replacement Therapy (CRRT) for patients weighing 20 kilograms or more with acute renal failure and/or fluid overload. *Therapeutic Plasma Exchange (TPE) therapy for patients weighing 20 kilograms or more with diseases where removal of plasma components is indicated.
Reason for recall
Firm has received reports of device operators failing to adhere to instructions for use pertaining to the safe unloading of disposable sets from the Prismaflex Control Unit. Additionally, for software versions 5.10 and 6.10, the programmed syringe size for the syringe pump may revert to safe default values unintentionally.
Recall Profile
| Attribute | Value |
|---|---|
| Agency | U.S. Food and Drug Administration |
| Severity class | Moderate (Class II) |
| Status | Terminated |
| Recall number | Z-1280-2018 |
| Date reported | April 11, 2018 |
| Date initiated | February 15, 2017 |
| Recalling firm | Baxter Healthcare Corporation |
| Firm location | Deerfield, IL |
| Affected scope | 3,440 units |
| Distribution | Worldwide Distribution - USA (nationwide) Distribution and to the countries of : Algeria, Armenia, Australia, Bahrain, Belarus, Belgium, Canada, China, Cyprus, Denmark, Egypt, France, Germany, Great Britain, Greece, Ireland, Italy, Alban… |
Profile values are sourced directly from the official FDA Devices enforcement record. Source: U.S. Food and Drug Administration.
What to do with this recall
Match your product against the recall record, then act on the agency remedy.
- Check the recall number (Z-1280-2018) and product description against the item you own. Search the archive
- Confirm the current status with FDA Devices before acting, recall details can be updated.
- Follow the documented remedy (refund, replacement, repair, or disposal) rather than general advice. What to do next
This page summarizes the official FDA Devices record for research and awareness; it is not legal, medical, or safety advice. Verify with the issuing agency before acting.
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Nationwide recalls with similar severity or category timing
Drug and device notices outside this firm and state, matched by severity timing and product category.
Similar severity · nearest report date
Same archive severity grade (Moderate), closest by report date among other firms and states.
Similar Medical Devices · nearest report date
Same product category, closest by report date among other firms and states (deduped against the severity set).
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Methodology · Corrections · Archive as of August 2026