Baxter Preveleak Surgical Sealant recall for inaccurate marketing brochure
Baxter Healthcare has recalled a marketing brochure for its Preveleak Surgical Sealant due to inaccurate content that does not align with the product's Instructions for Use. Healthcare providers and consumers should consult the accurate product Instructions for Use and Prescribing Information.
What this means for you
Real risk of harm even if no illness or injury has been reported yet. Stop using the product and follow the agency's guidance.
Our severity reasoning: This is a Class II FDA recall of a medical device used in cardiovascular surgery, a high-risk procedure. The inaccurate marketing brochure creates a risk-of-harm situation where healthcare providers might misuse the product based on incorrect information. No illnesses or injuries have been reported. Per the severity rubric, risk-of-harm products where injury has not yet been reported score 3 (High).
Plain-English summary
Baxter Healthcare Corporation has recalled its Cardiovascular Surgery marketing brochure (US-AS46-220001) for Preveleak Surgical Sealant (Product Code ADS201808). The brochure contains inaccurate content that does not align with the product's Instructions for Use and Prescribing Information.
The affected product was distributed nationwide across the United States. Healthcare providers and facilities that received this marketing brochure should review the official Instructions for Use and Prescribing Information to ensure proper use of the product.
Healthcare providers and consumers should not rely on the recalled marketing brochure and should instead consult the official Instructions for Use and Prescribing Information provided by Baxter Healthcare. This is a Class II FDA recall.
The recalled product
- Product
- Baxter Preveleak Surgical Sealant, Product Codes: ADS201808
- Manufacturer
- Baxter Healthcare Corporation
- Hazard
- mis-labeling
Is your product affected?
Check your packaging against the codes below. If any of them match, the product is part of this recall.
Lot numbers (2)
- UDI/DI 5413765583582
- All serial numbers
Distribution
Distributed nationwide across the United States.
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