Events

Recall of Device Recall SporAmpule Biological Indicator

According to U.S. Food and Drug Administration, this recall involved a device in United States that was produced by Mesa Laboratories Bozeman Manufacturing Facility.

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
    79374
  • Event Risk Class
    Class 2
  • Event Number
    Z-1274-2018
  • Event Initiated Date
    2018-02-12
  • Event Status
    Terminated
  • Event Country
    United States
  • Event Terminated Date
    2018-07-03
  • Event Source
    USFDA
  • Event Source URL
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=162162
  • 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
    Indicator, biological sterilization process - Product Code FRC
  • Reason
    The concentration of bromocresol purple in the recalled lots does not conform to specification.
  • Action
    Per the Recall Strategy, consignees have been requested to immediately discontinue use and discard according to site procedures.

Device

Device Recall SporAmpule Biological Indicator

Manufacturer

Mesa Laboratories Bozeman Manufacturing Facility
  • Manufacturer Address
    Mesa Laboratories Bozeman Manufacturing Facility, 625 Zoot Way, Boseman MT 59718
  • Source
    USFDA