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 Bioscience.

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
    55825
  • Event Risk Class
    Class 2
  • Event Number
    Z-1948-2010
  • Event Initiated Date
    2010-01-14
  • Event Date Posted
    2010-07-02
  • Event Status
    Terminated
  • Event Country
    United States
  • Event Terminated Date
    2010-12-22
  • Event Source
    USFDA
  • Event Source URL
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=91968
  • 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
    Polymerizing Sealant - Product Code NBE
  • Reason
    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.
  • Action
    The recall notification was initiated on January 14, 2010 with the firm sending a Product Recall letter and attached Customer Reply Form to the affected consignees. The recall letter informed the consignees of the reason for recall and requested them to immediately stop the usage/distribution of the lots noted above and to quarantine any units you may still have in your inventory. The letter provided instruction for product return. The letter also requested the consignees to please forward the recall information as appropriate to other services/facilities/departments that they may have provided this product to. Consignees were instructed to complete the Customer Reply Form, and fax it as soon as possible to 888-345-4261. Consignees with questions were instructed to contact Stericycle at 877-870-4486.

Device

Device Recall Coseal Surgical Sealant
  • Model / Serial
    Lot Numbers: HA080828, HA080841, HA081101, HA081216,  HA081217, HA090113, HA090225, HA090226, & HA090427.
  • Product Classification
    General and Plastic Surgery Devices
  • Device Class
    3
  • Implanted device?
    Yes
  • Distribution
    Nationwide Distribution
  • Product Description
    Coseal Surgical Sealant 2mL, Product Codes: 934070 & 934073. || Indicated for use in vascular reconstructions to achieve adjunctive hemostasis.
  • Manufacturer
    Baxter Bioscience

Manufacturer

Baxter Bioscience
  • Manufacturer Address
    Baxter Bioscience, 1 Baxter Way, Westlake Village CA 91362-3811
  • Manufacturer Parent Company (2017)
    Baxter International
  • Source
    USFDA