FDAFDA · Food and drugs·Recall number Z-0657-2024
Baxter Coseal Premix, Surgical Sealant, Product Codes: a) 934070; b) 934071; c) 934072
Published January 17, 2024 · Recall initiated: December 6, 2023
Status when published: Ongoing — openFDA updates weekly, so this field may not reflect the current status. Always confirm with the official notice.
What's the 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).
What to do
Voluntary: Firm initiated · Letter
Recall details
- Manufacturer
- Baxter Healthcare Corporation
- Distributor
- US Nationwide distribution.
- Lot
- All serial numbers a) Product code 934070, UDI/DI 5413765404610; b) Product code 934071, UDI/DI 5413765404627; c) Product code 934072, have no UDI/DI.
- Risk classification
- Class II
- Area (FDA)
- device
- Country
- United States
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