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Coseal Surgical Sealant

BAXTER HEALTHCARE CORPORATION · Model 934072 · UDI-DI 05413765404634

NBE Prescription

510(k) clearances

331

Adverse events (14 deaths)

Recalls

Facilities

Description

Coseal Surgical Sealant (Coseal) is composed of two synthetic polyethylene glycols (PEGs), a dilute hydrogen chloride solution and a sodium phosphate/sodium carbonate solution. These components come in a kit that includes an applicator(s). At the time of administration, the mixed PEGs and solutions form a hydrogel that adheres to tissue, synthetic graft materials and covalently bonds to itself

Recalls

Date	Firm	Reason
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
2016-05-12	Baxter Healthcare Corp	Potential for incomplete dissolution of the polyethylene glycol (PEG) component during the reconstitution of the product, which may affect the consistency of the hydrogel formation
2016-05-12	Baxter Healthcare Corp	Potential for incomplete dissolution of the polyethylene glycol (PEG) component during the reconstitution of the product, which may affect the consistency of the hydrogel formation
2016-05-12	Baxter Healthcare Corp	Potential for incomplete dissolution of the polyethylene glycol (PEG) component during the reconstitution of the product, which may affect the consistency of the hydrogel formation
2014-10-17	Mallinckrodt Manufacturing LLC	Product was improperly labeled leading to improper storage.
2012-08-13	Neomend Inc	Product was distributed with an incorrect expiration date. Product was labeled with an expiration date of 2013-04 and should have been labeled with 2012-09.
2011-07-28	Baxter Healthcare Services L.P.	The recall is being conducted as a precautionary measure due to out of specification results observed at the 24 months time point (out of 24-month licensed shelf life to expiration
2010-01-14	Baxter Bioscience	The recall is being conducted as a precautionary measure due to out of specification results at the 18 month and 21 month time points (out of the 24 month licensed shelf life to ex
2010-01-14	Baxter Bioscience	The recall is being conducted as a precautionary measure due to out of specification results at the 18 month and 21 month time points (out of the 24 month licensed shelf life to ex

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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.