Events

Recall of Vapofils with Stainless Steel Block Ends, Item Number V0507F (Isoflurane). The vapofil is a keyed anesthetic transfer tube that transfers the anesthetic from the bottle to the vaporizer.

According to U.S. Food and Drug Administration, this recall involved a device in United States that was produced by Southmedic 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
    35358
  • Event Risk Class
    Class 2
  • Event Number
    Z-1189-06
  • Event Initiated Date
    2006-04-21
  • Event Date Posted
    2006-07-04
  • Event Status
    Terminated
  • Event Country
    United States
  • Event Terminated Date
    2012-03-06
  • Event Source
    USFDA
  • Event Source URL
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=45923
  • 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
    Vaporizer, Anesthesia, Non-Heated - Product Code CAD
  • Reason
    Southmedic has initiated this recall because their japanese distributor received field reports of leaking vapofils. leakage may cause non-toxic spills in the hospital environment, distraction of practitioners during conduct of anesthesia and surgery, and may damage certain plastic equipment. leakage may also expose patients to low concentrations of volatile anesthetics.
  • Action
    Recall letters were sent to both US consignees via US Postal Service delivery with signature receipt required on April 21, 2006. Each letter included a Recall and Effectiveness Check Form for each consignee to fill out and fax to Southmedic. U.S. and international consignees were instructed to examine inventory immediately to identify if they have any product on hand, discontinue the distribution of these products and return all affected products to Southmedic. Consignees were also instructed to immediately notify their customers if they have further distributed these products.

Device

Vapofils with Stainless Steel Block Ends, Item Number V0507F (Isoflurane). The vapofil is a key...
  • Model / Serial
    Lot numbers : I02156, I07205, I03096, I02286, & I12095
  • Product Classification
    Anesthesiology Devices
  • Device Class
    2
  • Implanted device?
    No
  • Distribution
    US in FL & NJ Worldwide in Australia, Belgium, Ecuador, Germany, Japan, Netherlands, Sri Lanka, Taiwan, & United Arab Emerates
  • Product Description
    Vapofils with Stainless Steel Block Ends, Item Number V0507F (Isoflurane). The vapofil is a keyed anesthetic transfer tube that transfers the anesthetic from the bottle to the vaporizer.
  • Manufacturer
    Southmedic Inc

Manufacturer

Southmedic Inc
  • Manufacturer Address
    Southmedic Inc, Po Box 1365, Barrie Canada Ontario
  • Source
    USFDA