Z-1522-2024Class II

Surgical Tools and Cardiovascular Specialty marketing brochures, Reference numbers: US-AS18-210002 Surgical...

Name: Z-1522-2024 Surgical Tools and Cardiovascular Specialty marketing brochures, Reference numbers: US-AS18-210002 Surgical...
Creator: Baxter Healthcare Corporation
Published: 2024-02-22
License: https://open.fda.gov/license/

Baxter Healthcare Corporation / initiated 2024-02-22 / Open, Classified / root cause: labeling and UDI

FDA source

Baxter Healthcare Corporation began a recall of Surgical Tools and Cardiovascular Specialty marketing brochures, Reference numbers: US-AS18-210002 Surgical Tools Brochure 2021, US-AS18-210004 Surgical Tools... on 2024-02-22. FDA classified it as Class II and gives the reason as "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...". As of 2026-09-10, the recall status on record is Open, Classified, and MDM tags the root cause as labeling and UDI.

Recall record

Recall number: Z-1522-2024
Classification: Class II
Status: Open, Classified
Initiated: 2024-02-22
Posted: 2024-04-12
Recalling firm: Baxter Healthcare Corporation
Product: 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
Product code: DXC Clamp, Vascular
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).
Root cause tag: labeling and UDI
FDA root cause: Under Investigation by firm
Action: Baxter issued an IMPORTANT PRODUCT INFORMATION notice to its consignees on 02/22/2024 via USPS First Class Mail. The notice explained the issue with the marketing brochures, the potential hazards, and requested the following actions be taken: Healthcare providers may continue to safely use the Flo-Rester Disposable Internal Vessel Occluder, Flo-Thru Intraluminal Shunt, Vascular Probe Intravascular Probe while following the associated Instructions for Use. 2. Cease any further distribution of the Surgical Tools and Cardiovascular Specialty marketing brochures for the products listed above. All copies of the following materials should be promptly discarded: Surgical Tools Brochure 2021 - US (US-AS18-210002), Surgical Tools Website v1 (US-AS18-210004), and CV Specialty Brochure US version (US-AS46-230002). The reference numbers can be found at the bottom of the last page of the brochures. 3. If you received this communication directly from Baxter, please acknowledge receipt by responding on our customer portal at https://BaxterFieldActionCustomerPortal.onprocess.com,
Quantity in commerce: 83971 units
Distribution: Worldwide distribution - US Nationwide and the countries of Canada, Ireland, United Kingdom, and Hong Kong.
Product codes and lots: 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

Enforcement reports

One row per recalled product line

FDA enforcement reports joined to recall event Z-1522-2024
Recall number	Class	Status	Voluntary or mandated	Report date	Classified
Z-1522-2024	Class II	Ongoing	Voluntary: Firm initiated	2024-04-24	2024-04-12
Z-1523-2024	Class II	Ongoing	Voluntary: Firm initiated	2024-04-24	2024-04-12
Z-1524-2024	Class II	Ongoing	Voluntary: Firm initiated	2024-04-24	2024-04-12

Product code DXC

K942812Class IIFlo-Rester Disposable Vessel OccluderBio-Vascular, Inc. / cleared 1994-08-01

MDM coverage of this record lists here, newest first.

About this record

Sourced from the FDA device recall database and the FDA enforcement reports, both ingested from openFDA. The recall record supplies the product, the reason and the product code; the enforcement report supplies the classification. The two datasets are exported by FDA on different days, and the date above is the older of the two, so nothing on this page is newer than it says.

MDM adds the root cause tag, derived from FDA’s own root cause text, and the cross-links to the product code, the clearances named on the record and MDM coverage. Where a recall has not been joined to an enforcement report, no classification is shown.

Data as of 2026-09-30, the FDA export date for this dataset. Page last changed 2026-09-05. View this recall on fda.gov (opens on fda.gov)