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: Vascular Probe, Item Numbers: a) 7081015, b) 7081015ES, c) 7081520, d) 7081520ES, e) 7082025, f) 7082025ES, g) 7151015, h) 7151015ES, i) 7151520, j) 7151520ES, k) 7152025, l) 7152025ES, m) 7451015, n) 7451015ES, o) 7451520, p) 7451520ES, q) 7452025, r) 7452025ES
Class I - DangerousWhat Should You Do?
- Check if you have this product: 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-Thru Intraluminal Shunt: ALL SERIAL NUMBERS: a) 7081015, UDI/DI00085412532554; b) 7081015ES, UDI/DI00085412532646; c) 7081520, UDI/DI00085412532561; d) 7081520ES, UDI/DI00085412532653; e) 7082025, UDI/DI00085412532578; f) 7082025ES, UDI/DI00085412532660; g) 7151015, UDI/DI00085412532585; h) 7151015ES, UDI/DI00085412532677; i) 7151520, UDI/DI00085412531908; j) 7151520ES, UDI/DI00085412531915; k) 7152025, UDI/DI00085412531922; l) 7152025ES, UDI/DI00085412531939; m) 7451015, UDI/DI00085412531946; n) 7451015ES, UDI/DI00085412531953; o) 7451520, UDI/DI00085412531960; p) 7451520ES, UDI/DI00085412531977; q) 7452025, UDI/DI00085412531984; r) 7452025ES, UDI/DI00085412531991
- Do not eat it: Even if it looks and smells fine, do not consume this product.
- Throw it away or return it: You can return the product to the store for a full refund.
- Seek medical attention if needed: If you've consumed this product and feel unwell, contact your doctor immediately.
- Report problems: Report any issues to the FDA's Safety Reporting Portal.
⚠️ Emergency: If you experience severe symptoms after consuming this product, call 911 or Poison Control at 1-800-222-1222.
Recall Details
- Company:
- Baxter Healthcare Corporation
- 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).
- Classification:
- Class I - Dangerous
Dangerous or defective products that predictably could cause serious health problems or death.
- Status:
- ongoing
Product Information
Full 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: Vascular Probe, Item Numbers: a) 7081015, b) 7081015ES, c) 7081520, d) 7081520ES, e) 7082025, f) 7082025ES, g) 7151015, h) 7151015ES, i) 7151520, j) 7151520ES, k) 7152025, l) 7152025ES, m) 7451015, n) 7451015ES, o) 7451520, p) 7451520ES, q) 7452025, r) 7452025ES
Product Codes/Lot Numbers:
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-Thru Intraluminal Shunt: ALL SERIAL NUMBERS: a) 7081015, UDI/DI00085412532554; b) 7081015ES, UDI/DI00085412532646; c) 7081520, UDI/DI00085412532561; d) 7081520ES, UDI/DI00085412532653; e) 7082025, UDI/DI00085412532578; f) 7082025ES, UDI/DI00085412532660; g) 7151015, UDI/DI00085412532585; h) 7151015ES, UDI/DI00085412532677; i) 7151520, UDI/DI00085412531908; j) 7151520ES, UDI/DI00085412531915; k) 7152025, UDI/DI00085412531922; l) 7152025ES, UDI/DI00085412531939; m) 7451015, UDI/DI00085412531946; n) 7451015ES, UDI/DI00085412531953; o) 7451520, UDI/DI00085412531960; p) 7451520ES, UDI/DI00085412531977; q) 7452025, UDI/DI00085412531984; r) 7452025ES, UDI/DI00085412531991
Official Source
Always verify recall information with the official FDA source:
View on FDA.govFDA Recall Number: Z-1524-2024
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