Agency classClass IIOur severity:High FDA (Devices)·Z-0660-2024·Announced 2024-01-17

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.

The agency’s classification

FDA (Devices): Class II

Class II is a situation in which use of or exposure to a violative product may cause temporary or medically reversible adverse health consequences, or where the probability of serious adverse health consequences is remote.

This is the agency’s own classification, taken from its notice. The severity score below is our assessment, not the agency’s. How recall classes work

What this means for you

Our assessment, not the agency’s: severity 3/5 (High).

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
Category: Medical Device — Surgical Sealant
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.

Part of a larger recall action

This product is one of 14 recalled by Baxter Healthcare Corporation under a single FDA (Devices) recall action. The agency files each product separately, so the size of the action is not visible from this page alone.

See all 14 products in this recall →

Same manufacturer · Baxter Healthcare Corporation

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Same hazard · mis labeling