Events

Recall of Device Recall IS Can Disposable CO2 absorber

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

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
    60381
  • Event Risk Class
    Class 2
  • Event Number
    Z-0518-2012
  • Event Initiated Date
    2011-02-09
  • Event Date Posted
    2012-01-11
  • Event Status
    Terminated
  • Event Country
    United States
  • Event Terminated Date
    2013-01-15
  • Event Source
    USFDA
  • Event Source URL
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=105216
  • 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
    Absorber, carbon-dioxide - Product Code BSF
  • Reason
    Intersurgical incorporated has issued a voluntary recall of the is cans carbon dioxide absorber due to a possibility that loose granules may enter the inspiratory path of the breathing system.
  • Action
    Intersurgical Inc. sent an "URGENT MEDICAL DEVICE RECALL" letter dated February 8, 2011 to all affected customers. The letter described the product, problem, and actions to be taken by the customers. The letter instructs customers to immediately discontinue use and quarantine any affected product found. A Recall Response Form was attached to the letter for customers to complete and return via fax at 315-451-3696, Attn: Customer Service. Contact Customer Service at 1-800-828-9633 if you have questions concerning this recall.

Device

Device Recall IS Can Disposable CO2 absorber
  • Model / Serial
    Product 2194: Lot numbers 1101240 (exp. date 2013-04), 1101425 (exp. date 2013-05), 1101426 (exp. date 2013-05), 1101902 (exp. date 2013-06); Product 2195: Lot numbers 1102927 (exp. date 2013-08), 1102596 (exp. date 2013-07), 1101423 (exp. date 2013-05), 1102596 (exp. date 2013-07); Product 2196: Lot numbers 1100392 (exp. date 2013-02), 1101241 (exp. date 2013-04), 1101426 (exp. date 2013-05), 1103379 (exp. date 2016-01); Product 2197: Lot numbers 1101281 (exp. date 2013-05), 1102597 (exp. date 2013-08); Product 2198: Lot numbers 1101107 (exp. date 2013-04), 1101427 (exp. date 2013-05), 1101428 (exp. date 2013-05).
  • Product Classification
    Anesthesiology Devices
  • Device Class
    1
  • Implanted device?
    No
  • Distribution
    Worldwide Distribution- USA (nationwide) including the states of Florida, North Carolina, New York, Ohio, and the country of Canada.
  • Product Description
    The IS Can Disposable CO2 absorber x 6 --- || Carbon Dioxide absorbent for use on GE rebreathing systems --- || Manufactured in the United Kingdom for: Intersurgical Incorporated --- || 417 Electronics Parkway, Liverpool, NY 13088. || Intended use: GE Healthcare anesthetic machines: S5 Aespire, S5 Avance, Aisys. The Intersurgical IS Can is for use with air, oxygen, nitrous oxide, halothane, enflurane, isoflurane, desflurane and sevoflurane.
  • Manufacturer
    Intersurgical Inc

Manufacturer

Intersurgical Inc
  • Manufacturer Address
    Intersurgical Inc, 417 Electronics Pkwy, Liverpool NY 13088
  • Source
    USFDA