Events

Recall of Vascular Loop

According to U.S. Food and Drug Administration, this recall involved a device in United States that was produced by International Biophysics 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
    71911
  • Event Risk Class
    Class 2
  • Event Number
    Z-2424-2015
  • Event Initiated Date
    2015-08-07
  • Event Date Posted
    2015-08-19
  • Event Status
    Terminated
  • Event Country
    United States
  • Event Terminated Date
    2016-03-01
  • Event Source
    USFDA
  • Event Source URL
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=139393
  • 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
    Instruments, surgical, cardiovascular - Product Code DWS
  • Reason
    It was discovered that the heat seal placed onto sterile pouches may not meet strength acceptance criteria.
  • Action
    The recalling firm began notifying their affacted customers on 7/2/2015

Device

Vascular Loop
  • Model / Serial
    031715-3418, 050815-3513, 052115-3540, 033015-3435, 052115-3542, 031615-3417, 050815-3514, 052115-3543, 033015-3436, 050815-3515, 060915-3578, 041715-3478, 033015-3437, 050815-3516, 052215-3545, 042015-3482, 052115-3541
  • Product Classification
    Cardiovascular Devices
  • Device Class
    1
  • Implanted device?
    No
  • Distribution
    Worldwide - United States Nationwide and the countries of: Germany, Norway, Turkey, Chile, Pakistan, and Republic of South Africa
  • Product Description
    IBC Vascular Loop Catalog Number CH111, CH112, CH113, CH114, CH115, CH116, CH118 || Product Usage: || The IBC Vascular Loop is a single-use, disposable loop used in occluding, retracting, and identifying arteries, veins, tendons, and nerves in surgical procedures.
  • Manufacturer
    International Biophysics Corp.

Manufacturer

International Biophysics Corp.
  • Manufacturer Address
    International Biophysics Corp., Bldg 2, Ste 275, 2101 E Saint Elmo Rd, Austin TX 78744-1015
  • Manufacturer Parent Company (2017)
    International Biophysics Corp
  • Source
    USFDA