FDAClass IIJanuary 17, 2024

Baxter Vascular Probe recall

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)…

Why was Baxter Vascular Probe recalled?

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).

What should I do if I have this product?

The recall is ongoing. Follow the firm and FDA instructions.

What to do with a recalled product: refunds, receipts, safe disposal and how to report a problem.

Is my product affected?

Compare the item in your hand with every identifier below from the official FDA record. Only products that match the listed product and lot, UPC or model codes are part of this recall.

Which lot codes, UPCs or models are affected?

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

Product
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)…
Recalling firm
Baxter Healthcare Corporation
Distribution
US Nationwide distribution.
Recall date
January 17, 2024
Classification
Class II
Status
Ongoing
Agency
FDA (device)
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