CLASS II ONGOING Device recall · Reported 17 Jan 2024 · FDA Enforcement Report

Baxter FloSeal Hemostatic Matrix NL, Product Codes: ADS201883 recalled

Baxter Healthcare is recalling Baxter FloSeal Hemostatic Matrix NL, Product Codes: ADS201883, distributed nationwide in the US. The recall was initiated on 6 Dec 2023 and the FDA has classified it as Class II.

Check your package

Lot, batch or date codesUDI/DI 85412656304, All serial numbers

Stop using the device if the notice says to, and contact the manufacturer or your healthcare provider for the correction or replacement.

Recall details

Recall number: Z-0667-2024
FDA event ID: 93503
Recalling firm: Baxter Healthcare, Deerfield, IL
Classification: Class II
Status: Ongoing
Recall initiated: 6 Dec 2023
FDA classified: 5 Jan 2024
Reported: 17 Jan 2024
Type: Voluntary: Firm initiated
Customers notified by: Letter
Reason category: Labeling Errors
Device type: Other Medical Devices

Timeline

6 Dec 2023	Recall initiated by company
5 Jan 2024	Classified by FDA	+30 days
17 Jan 2024	Published in enforcement report	+12 days

Companies usually start a recall weeks before the FDA classifies and publishes it; the gap above is that lag.

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).

Product as listed by the FDA

Baxter FloSeal Hemostatic Matrix NL, 5 mL, Product Codes: ADS201883

Where it was distributed

US Nationwide distribution.

Nationwide

Questions about this recall

Is Baxter FloSeal Hemostatic Matrix NL, Product Codes: ADS201883 recalled?

Yes. Baxter Healthcare recalled Baxter FloSeal Hemostatic Matrix NL, Product Codes: ADS201883 on 6 Dec 2023. The recall is Class II and its status is Ongoing. Recall number Z-0667-2024.

Why was it recalled?

Which lots are affected?

UDI/DI 85412656304, All serial numbers

Where was it sold?

US Nationwide distribution.

What should I do if I have it?

Stop using the device if the notice says to, and contact the manufacturer or your healthcare provider for the correction or replacement.

What does Class II mean?

Class II means the product may cause temporary or medically reversible health problems, or the probability of serious harm is remote.

Read the official FDA notice · Source record retrieved 21 Sep 2026. The FDA describes openFDA data as unvalidated; the official notice takes precedence. This page reports the record and gives no medical advice.

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