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FLOSEAL HEMOSTATIC MATRIX

BAXTER HEALTHCARE CORPORATION · Model ADS201883 · UDI-DI 00085412656304

PMX Prescription
0
510(k) clearances
25
Adverse events
2
Recalls
12
Facilities

Description

Floseal Matrix is indicated in surgical procedures (other than in ophthalmic) as an adjunct to hemostasis when control of bleeding by ligature or conventional procedures is ineffective or impractical.

Recalls

DateFirmReason
2023-12-06Baxter Healthcare CorporationCardiovascular 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 produ
2018-05-30Baxter Healthcare CorporationBaxter r recalled this device due to the use of an incorrect plastic formulation in the manufacture of the blue luer component of the FLOSEAL malleable tips.

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Data compiled from public U.S. FDA sources (GUDID, 510(k)/PMA, MAUDE, recalls, establishment registration). Adverse-event reports are unverified and do not establish causation. Informational only — not medical, clinical, or regulatory advice.