Surgical Tools and Cardiovascular Specialty marketing brochures, Reference numbers: US-AS18-210002 Surgical Tools Brochu

FDA device recall Z-1522-2024 · posted 2024-04-12 · Open, Classified

Recall details

Recalling firm

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).

Action taken

Baxter issued an IMPORTANT PRODUCT INFORMATION notice to its consignees on 02/22/2024 via USPS First Class Mail. The notice explained the issue with the marketing brochures, the potential hazards, and requested the following actions be taken: Healthcare providers may continue to safely use the Flo-Rester Disposable Internal Vessel Occluder, Flo-Thru Intraluminal Shunt, Vascular Probe Intravascular Probe while following the associated Instructions for Use. 2. Cease any further distribution of the Surgical Tools and Cardiovascular Specialty marketing brochures for the products listed above. All copies of the following materials should be promptly discarded: Surgical Tools Brochure 2021 - US (US-AS18-210002), Surgical Tools Website v1 (US-AS18-210004), and CV Specialty Brochure US version (US-AS46-230002). The reference numbers can be found at the bottom of the last page of the brochures. 3. If you received this communication directly from Baxter, please acknowledge receipt by responding on our customer portal at https://BaxterFieldActionCustomerPortal.onprocess.com,

Root cause

Under Investigation by firm

Status

Open, Classified

Product code

DXC

Quantity affected

83971 units

Distribution

Worldwide distribution - US Nationwide and the countries of Canada, Ireland, United Kingdom, and Hong Kong.

Date initiated

2024-02-22

Date posted

2024-04-12

Location

Deerfield, IL

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