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Baxter FloSeal Hemostatic Matrix RECOTHROM, Product Codes: a) ADS202105, 5mL-6 PK US b) ADS202...

FDA Recall #Z-0662-2024 — Class II — December 6, 2023

Recall #Z-0662-2024 Date: December 6, 2023 Classification: Class II Status: Ongoing

Product Description

Baxter FloSeal Hemostatic Matrix RECOTHROM, Product Codes: a) ADS202105, 5mL-6 PK US b) ADS202110, 10mL US

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).

Recalling Firm

Baxter Healthcare Corporation — Deerfield, IL

Classification

Class II — May cause temporary or medically reversible adverse health consequences.

Product Type

Devices

Distribution

US Nationwide distribution.

Code Information

All serial numbers a) ADS202105, UDI/DI 85412827957; b) ADS202110, UDI/DI 85412827896

Status

Ongoing

Voluntary / Mandated

Voluntary: Firm initiated

What Should You Do?

Stop using this medical device immediately and consult your healthcare provider. Contact the recalling firm for instructions on return or replacement. If you experienced an adverse event, inform your doctor.

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