Baxter Healthcare Corporation: Baxter Vascular Probe, Product Codes: a) 7081015: 8CM, 1- 1.5 MM GLOBAL, b) 7081520: 8CM, 1.5-2 MM GLOBAL, c) 7082025: 8CM, 2-2.5 MM GLOBAL, d) 7151015: 15CM, 1-1.5 MM G

Hazard

Cardiovascular Surgery marketing brochure (US-AS46-220001) that was distributed for the products listed below contains inaccurate content that does not align with some of the products Instructions for Use (IFU) or Prescribing Information (PI).

Details from the source

Reason for recall: Cardiovascular Surgery marketing brochure (US-AS46-220001) that was distributed for the products listed below contains inaccurate content that does not align with some of the products Instructions for Use (IFU) or Prescribing Information (PI). Distribution: US Nationwide distribution. Lot/code info: a) 7081015: UDI/DI 0338-9564-17, b) 7081520: UDI/DI 0338-9564-18, c) 7082025: UDI/DI 0338-9564-19, d) 7151015: UDI/DI 0338-9564-12, e) 7151520: UDI/DI 0338-9564-11, f) 7152025: UDI/DI 0338-9564-13, g) 7451015: UDI/DI 0338-9564-14, h) 7451520: UDI/DI 0338-9564-15, i) 7452025: UDI/DI 0338-9564-16, j) 7081015ES: UDI/DI 0338-9564-10, k) 7081520ES: UDI/DI 0338-9564-26, l) 7082025ES: UDI/DI 0338-9564-27, m) 7151015ES: UDI/DI 0338-9564-21, n) 7151520ES: UDI/DI 0338-9564-20, o) 7152025ES: UDI/DI 0338-9564-22, p) 7451015ES: UDI/DI 0338-9564-24, q) 7451520ES: UDI/DI 0338-9564-23, r) 7452025ES: UDI/DI 0338-9564-25, All serial numbers

Source

Official record: FDA (Device enforcement) ↗

Republished from the official source above; details can change — the source record controls.