Events

Recall of Device Recall COSEAL Surgical Sealant

According to U.S. Food and Drug Administration, this recall involved a device in United States that was produced by Baxter Healthcare Corp.

What is this?

A correction or removal action taken by a manufacturer to address a problem with a medical device. Recalls occur when a medical device is defective, when it could be a risk to health, or when it is both defective and a risk to health.

Learn more about the data here
  • Type of Event
    Recall
  • Event ID
    74139
  • Event Risk Class
    Class 2
  • Event Number
    Z-1839-2016
  • Event Initiated Date
    2016-05-12
  • Event Date Posted
    2016-05-31
  • Event Status
    Terminated
  • Event Country
    United States
  • Event Terminated Date
    2017-03-23
  • Event Source
    USFDA
  • Event Source URL
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=146452
  • Notes / Alerts
    U.S. data is current through June 2018. All of the data comes from the U.S. Food and Drug Administration, except for the category Manufacturer Parent Company.
    The Parent Company was added by ICIJ.
    The parent company information is based on 2017 public records.
  • Extra notes in the data
    Sealant,polymerizing - Product Code NBE
  • Reason
    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.
  • Action
    An Urgent Product Recall letter dated 5/13/16 was sent to customers to inform them that Baxter Healthcare Corporation is issuing a voluntary product recall for the product codes and lots listed below due to the 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. The letter provides the customers with the list of affected products, hazards involved, and actions to be taken. Customers with questions regarding the recall communication, are instructed to contact Baxter Product Surveillance at (800) 437-5176, 8-5pm, Monday-Friday.

Device

Device Recall COSEAL Surgical Sealant
  • Model / Serial
    HA160151, HA151205, HA151036, HA151035, HA160229
  • Product Classification
    General and Plastic Surgery Devices
  • Device Class
    3
  • Implanted device?
    Yes
  • Distribution
    Distributed US (nationwide) including Puerto Rico and in the Bahamas, Canada, and Singapore.
  • Product Description
    COSEAL Surgical Sealant Kit, 4 mL, Product Code: 934071; For use in vascular reconstructions to achieve adjunctive hemostasis by mechanically sealing areas of leakage.
  • Manufacturer
    Baxter Healthcare Corp

Manufacturer

Baxter Healthcare Corp
  • Manufacturer Address
    Baxter Healthcare Corp, 21026 Alexander Ct, Hayward CA 94545-1234
  • Manufacturer Parent Company (2017)
    Baxter International
  • Source
    USFDA