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 Services L.P..

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
    59861
  • Event Risk Class
    Class 2
  • Event Number
    Z-1614-2012
  • Event Initiated Date
    2011-07-28
  • Event Date Posted
    2012-05-16
  • Event Status
    Terminated
  • Event Country
    United States
  • Event Terminated Date
    2012-05-31
  • Event Source
    USFDA
  • Event Source URL
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=103883
  • 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
    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.
  • Action
    Baxter Healthcare sent an"URGENT PRODUCT RECALL" letter dated July 27, 2011 to all affected customers. The letter identifies the product, problem, and actions to be taken by the customers. The letter instructs customers to immediately stop the usage/distribution of the affected product and to quarantine any units that are in inventory. Instructions for obtaining replacement product were attached to the letter. Contact the firm at 1-800-423-2090 for questions concerning this recall.

Device

Device Recall Coseal Surgical Sealant.
  • Model / Serial
    Lot numbers: (2mL) HA100143, HA091236. (4mL) HA090950, HA090944, HA090843, HA090749, HA090947. (8mL) HA100132, HA100142
  • Product Classification
    General and Plastic Surgery Devices
  • Device Class
    3
  • Implanted device?
    Yes
  • Distribution
    Nationwide Distribution.
  • Product Description
    Coseal Surgical Sealant. || Coseal is an adjunctive surgical sealant.
  • Manufacturer
    Baxter Healthcare Services L.P.

Manufacturer

Baxter Healthcare Services L.P.
  • Manufacturer Address
    Baxter Healthcare Services L.P., 1 Baxter Pkwy, Building 3, Deerfield IL 60015-4625
  • Manufacturer Parent Company (2017)
    Baxter International
  • Source
    USFDA