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Coseal Surgical Sealant (Premixed)

by Baxter Bio Science

PMA P030039

Active United States

PMA

Valid until

No expiry

PMA approval is not time-limited

FDA recalls

1 ongoing

This device is named in the recall

Documents

PMA P030039↗

FDA record

Trust

Unverified

Registry data, not yet checked by deviCERTS. Source FDA PMA, synced 6 Oct 2026. What this means

Regulatory status

as of registry sync 6 Oct 2026

RegionAuthorizationNumberDateStatus
United StatesFDA PMAAPPR Approved NumberP030039 Date12 Dec 2003ApprovedStatusActive

Recalls

6 recalls · 1 ongoing · FDA

    • Ongoing Z-0657-2024 FDA Class II initiated 6 Dec 2023

    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).

    • Terminated Z-1838-2016 FDA Class II initiated 12 May 2016

    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 during use.

    • Terminated Z-1614-2012 FDA Unclassified (pre-2012) initiated 28 Jul 2011

    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) during a Coseal stability study. The parameter that is out specification is an indicator of possible failure for the product to gel appropriately . Coseal's failure to gel does not represent risk for the patient's life

  • 3 recalls, same reason

    • Terminated Z-1950-2010 FDA Unclassified (pre-2012) initiated 14 Jan 2010
    • Terminated Z-1948-2010 FDA Unclassified (pre-2012) initiated 14 Jan 2010
    • Terminated Z-1949-2010 FDA Unclassified (pre-2012) initiated 14 Jan 2010

    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 expiration) for the percent thiol substitution during a Coseal Stability study. The parameter that is out of specification is an indicator of possible failure for the product to gel appropriately.

Coverage

1 jurisdiction

United States of America
  • Active
  • Expiring
  • Withdrawn
  • Listed
  • Not covered

United States — FDA PMA Active

Specification

PMA

Trade Name
Coseal Surgical Sealant
Generic Name
Sealant, polymerizing
PMA Number
FDA Product Code
NBE
Device Class
Class III
Advisory Committee
Cardiovascular
FDA Decision
APPR Approved

Overview

AI-generated summary, 18 Sep 2026

Written by a language model from registry data. Not verified by deviCERTS or the manufacturer. The registry data above is the record.

The Coseal Surgical Sealant (Premixed) is a polymerizing sealant classified as a Sealant, Polymerizing, designed to achieve adjunctive hemostasis in vascular reconstructions. It mechanically seals areas of leakage to prevent blood loss during surgical procedures, supporting vascular integrity and stability.

This device is supplied as a premixed formulation and is intended for single-use in sterile surgical settings. It is approved for reference rights under PMA number P030039 and falls under FDA Class III regulatory classification (NBE product code). Storage and handling must comply with sterile medical device protocols to ensure efficacy and safety.

Questions

AI-generated answers, 18 Sep 2026

Written by a language model from registry data. Not verified by deviCERTS or the manufacturer. The registry data above is the record.

  • What is the primary clinical purpose of the Coseal Surgical Sealant (Premixed) in surgical procedures?

    The Coseal Surgical Sealant (Premixed) is designed to provide adjunctive hemostasis during vascular reconstructions by mechanically sealing areas where leakage may occur. This helps prevent blood loss and supports the stability and integrity of the vascular system during surgery.

  • Is the Coseal Surgical Sealant (Premixed) intended for reuse, or is it meant for single-use only?

    The Coseal Surgical Sealant (Premixed) is explicitly intended for single-use in sterile surgical settings. This ensures safety and efficacy, as reuse could compromise sterility and performance.

  • How should the Coseal Surgical Sealant (Premixed) be stored to maintain its integrity?

    Since it is a sterile medical device, the Coseal Surgical Sealant (Premixed) must be stored and handled according to sterile medical device protocols. This includes proper packaging, temperature control, and protection from contamination to preserve its effectiveness.

  • What regulatory pathway was followed for the approval of the Coseal Surgical Sealant (Premixed)?

    The Coseal Surgical Sealant (Premixed) was approved under the FDA’s Premarket Approval (PMA) pathway, specifically with PMA number P030039. This classification applies to Class III devices, which require rigorous review due to their higher risk.