FDA Device recall Z-0659-2024
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…
- FDA Device
- Class II
- ongoing
- Published 2024-01-17
On 2024-01-17 the FDA classified a Class II recall of 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… by Baxter Healthcare, citing 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 prod….
Read the official FDA Device notice
| Agency | FDA Device |
|---|---|
| Recall number | Z-0659-2024 |
| Classification | Class II |
| Status | ongoing |
| Initiated | 2023-12-06 |
| Published | 2024-01-17 |
| Last updated | 2026-09-13 11:57 UTC |
| Company | Baxter Healthcare |
| Distribution | US |
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) 7151015: 15CM, 1-1.5 MM GLOBAL, e) 7151520: 15CM, 1.5- 2 MM GLOBAL, f) 7152025: 15CM, 2- 2.5 MM GLOBAL, g) 7451015: 45CM, 1- 1.5 MM GLOBAL, h) 7451520: 45CM, 1.5- 2 MM GLOBAL, i) 7452025: 45CM, 2- 2.5 MM GLOBAL, j) 7081015ES: 8CM, 1-1.5 MM GLOBAL, k) 7081520ES: 8CM, 1.5- 2 MM GLOBAL, l) 7082025ES: 8CM, 2-2.5 MM GLOBAL, m) 7151015ES: 15CM, 1-1.5 MM GLOBAL, n) 7151520ES: 15CM, 1.5- 2 MM GLOBAL, o) 7152025ES: 15CM, 2-2.5 MM GLOBAL, p) 7451015ES: 45CM, 1-1.5 MM GLOBAL, q) 7451520ES: 45CM, 1.5-2 MM GLOBAL, r) 7452025ES: 45CM, 2-2.5 MM GLOBAL
Reason
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).
Identifiers
| 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/D…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 |
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Status history
No status changes recorded since RecallRadar first saw this recall on 2026-09-13 11:57 UTC. Current status: ongoing.
Source
Official record: https://api.fda.gov/device/enforcement.json?search=recall_number:%22Z-0659-2024%22
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