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Floseal Hemostatic Matrix
BAXTER HEALTHCARE CORPORATION · Model 1503349 · UDI-DI 00085412096094
0
510(k) clearances
2,123
Adverse events (93 deaths)
27
Recalls
35
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
| Date | Firm | Reason |
|---|---|---|
| 2026-03-25 | Davol, Inc. | Potential for product to contain foreign matter, confirmed to be inspect fragments. |
| 2024-04-23 | Ethicon, Inc. | Some applicator tips from these lots had open seals. |
| 2023-12-06 | Baxter Healthcare Corporation | 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 produ |
| 2023-12-06 | Baxter Healthcare Corporation | 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 produ |
| 2022-05-25 | Mckesson Medical-Surgical Inc. Corporate Office | Facility Temperature excursions (from June 2021-August 2021) prior to delivery; exposure to higher temperatures may have impacted product effectiveness. All lots received between 0 |
| 2013-03-28 | Integra LifeSciences Corporation | Due to the process deviation, product lots in question may have been released with higher levels of pyrogens than permitted by the specifications for the products. |
| 2013-03-28 | Integra LifeSciences Corporation | Due to the process deviation, product lots in question may have been released with higher levels of pyrogens than permitted by the specifications for the products. |
| 2013-03-28 | Integra LifeSciences Corporation | Due to the process deviation, product lots in question may have been released with higher levels of pyrogens than permitted by the specifications for the products. |
| 2013-03-28 | Integra LifeSciences Corporation | Due to the process deviation, product lots in question may have been released with higher levels of pyrogens than permitted by the specifications for the products. |
| 2012-10-24 | Superstat Corp | The recall was initiated because Superstat Corporation has confirmed that no documentation are available to verify that quarterly dose sterility audits were performed for the Super |
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Get your free API keyRead the docsData 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.