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
Related Recalls
Pumps were released without full testing being performed, including occlusion alarm testing.
Sterile Water for Irrigation, 250 mL, Single-Dose Plastic Bottle, Rx Only, Baxter Healthcare Corporation Deerfield, IL 60015 NDC: 0338-0004-02.
Baxter Healthcare
Presence of particulate matter: plastic particles from the bottle rim were observed floating into the solution
SIGMA Spectrum Infusion Pump, Model/Catalog Number: 35700BAX2
Baxter Healthcare
Certain pumps have potentially been released from service with defective grease applied to the cam and motor gears. Due to its low viscosity, the defective grease may lead to the device having insufficient lubrication on the cam, which could lead to premature wear of the mechanism assembly, resulting in over-infusion or a free-flow situation.