CLASS II ONGOING Device recall · Reported 24 Apr 2024 · FDA Enforcement Report
Surgical Tools and Cardiovascular Specialty marketing recalled
Baxter Healthcare is recalling Surgical Tools and Cardiovascular Specialty marketing brochures, Reference numbers, distributed nationwide in the US. The recall was initiated on 22 Feb 2024 and the FDA has classified it as Class II.
Check your package
Stop using the device if the notice says to, and contact the manufacturer or your healthcare provider for the correction or replacement.
Recall details
- Recall number
- Z-1522-2024
- FDA event ID
- 94119
- Recalling firm
- Baxter Healthcare, Deerfield, IL
- Classification
- Class II
- Status
- Ongoing
- Recall initiated
- 22 Feb 2024
- FDA classified
- 12 Apr 2024
- Reported
- 24 Apr 2024
- Type
- Voluntary: Firm initiated
- Customers notified by
- Letter
- Reason category
- Labeling Errors
- Device type
- Heart & Vascular Devices
Timeline
| 22 Feb 2024 | Recall initiated by company | |
| 12 Apr 2024 | Classified by FDA | +50 days |
| 24 Apr 2024 | Published in enforcement report | +12 days |
Companies usually start a recall weeks before the FDA classifies and publishes it; the gap above is that lag.
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).
Product as listed by the FDA
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-Rester Disposable Internal Vessel Occluder, Item Numbers: a) 50100, b) 50125, c) 50150, d) 50175, e) 50200, f) 50225, g) 50250, h) 50275, i) 50300, j) 50350, k) 50400, l) 50450BIOS, m) 60100, n) 60125BIOS, o) 60150BIOS, p) 60175, q) 60200BIOS, r) 60225BIOS, s) 60250BIOS, t) 60275, u) 60300, v) 60350, w) 60400BIOS, x) 60450BIOS
Where it was distributed
Worldwide distribution - US Nationwide and the countries of Canada, Ireland, United Kingdom, and Hong Kong.
Stores named: Online Retailers
Questions about this recall
Is Surgical Tools and Cardiovascular Specialty marketing brochures, Reference numbers recalled?
Yes. Baxter Healthcare recalled Surgical Tools and Cardiovascular Specialty marketing brochures, Reference numbers on 22 Feb 2024. The recall is Class II and its status is Ongoing. Recall number Z-1522-2024.
Why was it recalled?
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).
Which lots are affected?
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 Flo-Rester: ALL SERIAL NUMBERS: a) 50100, UDI/DI 00085412532592; b) 50125, UDI/DI 00085412532684; c) 50150, UDI/DI 00085412532608; d) 50175, UDI/DI 00085412532691; e) 50200, UDI/DI 00085412532431; f) 50225, UDI/DI 00085412532448; g) 50250, UDI/DI 00085412532455; h) 50275, UDI/DI 00085412532462; i) 50300, UDI/DI 00085412532479; j) 50350, UDI/DI 00085412532486; k) 50400, UDI/DI 00085412532493; l) 50450BIOS, UDI/DI 00085412532509; m) 60100, UDI/DI 00085412532516; n) 60125BIOS, UDI/DI 00085412532110; o) 60150BIOS, UDI/DI 00085412532127; p) 60175, UDI/DI 00085412532134; q) 60200BIOS, UDI/DI 00085412532141; r) 60225BIOS, UDI/DI 00085412532158; s) 60250BIOS, UDI/DI 00085412532523; t) 60275, UDI/DI 00085412532615; u) 60300, UDI/DI 00085412532530; v) 60350, UDI/DI 00085412532622; w) 60400BIOS, UDI/DI 00085412532547; x) 60450BIOS, UDI/DI 00085412532639
Where was it sold?
Worldwide distribution - US Nationwide and the countries of Canada, Ireland, United Kingdom, and Hong Kong.
What should I do if I have it?
Stop using the device if the notice says to, and contact the manufacturer or your healthcare provider for the correction or replacement.
What does Class II mean?
Class II means the product may cause temporary or medically reversible health problems, or the probability of serious harm is remote.
Read the official FDA notice · Source record retrieved 21 Sep 2026. The FDA describes openFDA data as unvalidated; the official notice takes precedence. This page reports the record and gives no medical advice.
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