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Floseal 1505288

by Baxter Healthcare Corp

Floseal 1505288 is a Class III device made by Baxter Healthcare Corp, approved under FDA PMA P990009 on 8 Dec 1999 and listed in FDA GUDID since 12 Apr 2017 (UDI-DI 00085412532738), active as of 23 Oct 2026. 2 FDA recalls are linked to it.

Active United States. Also listed in GUDID (US).

PMA

Valid until

No expiry

PMA approval is not time-limited

FDA recalls

2 ongoing

This device is named in the recall

Documents

PMA P990009

FDA submission, from GUDID

Trust

Unverified

Source GUDID, synced 23 Oct 2026.

Regulatory status

as of registry sync 23 Oct 2026

RegionAuthorizationNumberDateStatus
United StatesGUDID listing Number00085412532738 UDI-DI Date12 Apr 2017ListedStatusListed GUDID: in commercial distribution
United StatesFDA PMAAPPR from GUDID Approved NumberP990009 Date8 Dec 1999DecidedStatusActive

Official records

Across registries

2 registries list this device

  • FDA PMA P990009 decided 8 Dec 1999 Active
  • FDA GUDID UDI-DI 00085412532738 listed 12 Apr 2017 Listed

Recalls

3 recalls · 2 ongoing · FDA

    • Ongoing Z-0667-2024 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).

    • Ongoing Z-2957-2018 FDA Class II initiated 30 May 2018

    Baxter 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.

    • Terminated Z-2340-2008 FDA Unclassified (pre-2012) initiated 31 Jul 2008 on shared PMA P990009

    The recall is being conducted as a precautionary measure due to potential discoloration of the FloSeal material noted in six (6) non-medical complaints during delivery by the Endoscopic Applicator.

Recalls on a shared submission name another device cleared under the same FDA submission as this one.

Timeline

5 dated events

  1. Approved FDA PMA P990009
  2. Recall initiated FDA recalls Z-2340-2008
  3. Listed FDA GUDID 00085412532738
  4. Recall initiated FDA recalls Z-2957-2018
  5. Recall initiated FDA recalls Z-0667-2024

Coverage

1 jurisdiction

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  • Withdrawn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

United States — FDA PMA Active

Specification

GUDID

Trade name
Floseal
Generic name
Collagen haemostatic agent, non-antimicrobial
Model / Ref / Catalog
1505288
Primary DI / UDI-DI
00085412532738
PMA number
FDA product code
PMX
GMDN term
Collagen haemostatic agent, non-antimicrobial
Device class
Class III
Regulation number
878.4490
GUDID distribution status
In Commercial Distribution
Size
Total Volume — 5 Milliliter

Related devices

Category: Collagen haemostatic agent, non-antimicrobial

Cleared under the same submission (P990009)

and 1 more cleared under P990009

Similar devices

Other devices filed under FDA product code PMX (Absorbable collagen hemostatic agent with thrombin).

Other devices from Baxter Healthcare Corp

See all devices from Baxter Healthcare Corp →

Properties

  • Supplied sterile
  • Single use
  • Implantable
  • Prescription use
  • Combination product
  • Lot / batch number
  • Expiration date
Other properties (8, all answered No)