Events

Recall of Device Recall VIA Medical Collection Bag

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

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
    65341
  • Event Risk Class
    Class 2
  • Event Number
    Z-1531-2013
  • Event Initiated Date
    2013-05-24
  • Event Date Posted
    2013-06-11
  • Event Status
    Terminated
  • Event Country
    United States
  • Event Terminated Date
    2013-07-29
  • Event Source
    USFDA
  • Event Source URL
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=118591
  • 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
    pump, infusion, analytical sampling - Product Code LZF
  • Reason
    International biomedical has received reports of interference between the collection bag and the extension set connectors. evaluation of the affected components indicates that the collection bag connector can become occluded due to an over-tightening of the luer lock by the end user. to alleviate the occurrence of this issue in the fixture, the connector on the collection bag has been improved to.
  • Action
    International Biomedical decided to recall and sent "Product Bulletin" notification letters to their consignees on 05/24/2013 or 05/30/2013. The letter described the product issue and provided customers with recommended actions. Questions were directed to (512) 873-0033.

Device

Device Recall VIA Medical Collection Bag
  • Model / Serial
    Model/Part Number: 209-2113, or as part of kits 777-3103 and 777-3102. Collection Bag Lot numbers: 4389, 4465, 4478, 4516, 4530, 4430, 4489
  • Product Classification
    General Hospital and Personal Use Devices
  • Device Class
    2
  • Implanted device?
    No
  • Distribution
    Nationwide Distribution.
  • Product Description
    VIA Medical Collection Bag; The collection bag is an accessory waste bag used in conjunction with the sterile LVM blood gas sensor with the LVM Monitor. The collection bag is packaged in a tyvek pouch which is included in either replacement kit (777-3103) or LVM sensor kit (777-3102).
  • Manufacturer
    International Biomedical, Ltd.

Manufacturer

International Biomedical, Ltd.
  • Manufacturer Address
    International Biomedical, Ltd., 8508 Cross Park Dr, Austin TX 78754-4532
  • Manufacturer Parent Company (2017)
    International Biomedical, Ltd.
  • Source
    USFDA