FDA Devices recall · Reported April 24, 2024
Surgical Tools and Cardiovascular Specialty marketing brochures, Reference numbers: US-AS18-210002 Surgical Tools Brochure 2021, US-AS18-210004 Surgical Tools Website v1, and US-AS46-230002 CV Specialty Brochure US version which affect: Flo-Thru Intraluminal Shunt, Item Numbers: a) FT12100, b) FT12125, c) FT12150, d) FT12175, e) FT12200, f) FT12225, g) FT12250, h) FT12275, i) FT12300,
The Surgical Tools and Cardiovascular Specialty marketing brochures distributed for Flo-Rester Disposable Internal Vessel Occluder, Flo-Thru Intraluminal Shunt, and Vascular Probe…
Baxter Healthcare Corporation recalled Surgical Tools and Cardiovascular Specialty marketing brochures, Reference numbers: US-A… - a moderate-severity action.
Surgical Tools and Cardiovascular Specialty marketing brochures, Reference numbers: US-A… was recalled by Baxter Healthcare Corporation in April 24, 2024. Reason: The Surgical Tools and Cardiovascular Specialty marketing brochures distributed for Flo-Rester Disposable Int…. Check the official notice for the remedy. Verify recall #Z-1523-2024 with the FDA Devices before acting.
The recall
Baxter Healthcare Corporation issued this moderate-severity FDA Devices recall-The Surgical Tools and Cardiovascular Specialty marketing brochures distributed for Flo-Rester Disposable Int….
- Moderate
- severity level
- 113K units
- affected scope
- Class II
- classification
- April 24, 2024
- reported
Sourced from official FDA Devices enforcement records. Verify recall #Z-1523-2024 with the agency before acting. Full product description, hazard, remedy, and related recalls are below.
Recall Insight
This recall's affected scope (see the Recall Profile below) is large enough to require multi-state distribution tracking. 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
Surgical Tools and Cardiovascular Specialty marketing brochures, Reference numbers: US-AS18-210002 Surgical Tools Brochure 2021, US-AS18-210004 Surgical Tools Website v1, and US-AS46-230002 CV Specialty Brochure US version which affect: Flo-Thru Intraluminal Shunt, Item Numbers: a) FT12100, b) FT12125, c) FT12150, d) FT12175, e) FT12200, f) FT12225, g) FT12250, h) FT12275, i) FT12300,
Reason for recall
The Surgical Tools and Cardiovascular Specialty marketing brochures distributed for Flo-Rester Disposable Internal Vessel Occluder, Flo-Thru Intraluminal Shunt, and Vascular Probe Intravascular Probe contain inaccurate content that does not align with the products Instructions for Use (IFU).
Recall Profile
| Attribute | Value |
|---|---|
| Agency | U.S. Food and Drug Administration |
| Severity class | Moderate (Class II) |
| Status | Ongoing |
| Recall number | Z-1523-2024 |
| Date reported | April 24, 2024 |
| Date initiated | February 22, 2024 |
| Recalling firm | Baxter Healthcare Corporation |
| Firm location | Deerfield, IL |
| Affected scope | 112760 units |
| Distribution | Worldwide distribution - US Nationwide and the countries of Canada, Ireland, United Kingdom, and Hong Kong. |
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-1523-2024) 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