Recall of Device Recall OneTray Sealed Sterilization Container

According to U.S. Food and Drug Administration, this recall involved a device in United States that was produced by Innovative Sterlization Technologies LLC.

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
    72011
  • Event Risk Class
    Class 2
  • Event Number
    Z-0153-2016
  • Event Initiated Date
    2014-02-03
  • Event Date Posted
    2015-10-22
  • Event Status
    Terminated
  • Event Country
  • Event Terminated Date
    2016-02-04
  • Event Source
    USFDA
  • Event Source URL
  • 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
    Sterilization wrap containers, trays, cassettes & other accessories - Product Code KCT
  • Reason
    The wrong sterilization time was on the label. the label lists steam gravity 10 - 34 minutes at 270 degrees f instead of steam gravity 17 - 34 minutes at 270 degrees f.
  • Action
    The firm sent an Urgent Medical Device Recall letter dated September 14, 2015 to their customers. The letter identified the affected product, problem and actions to be taken. Customers were instructed to fill out the attached response SASE mailer and return to or fax to the address/number identified below: Innovative Sterilization Technologies, LLC, 7625 Paragon Road, Suite A Dayton, OH 45459, 937-286-3571 (C), 937-630-4346 (F), 937-619-0138 x 202 (Office), dbillman@ISTSterilization.com

Device

  • Model / Serial
    M2104 Lot # 044305, 044379, 044380 & 044418.  M2408 Lot # 044296, 022304, 044381, 044420, 044421 & 044422.
  • Product Classification
  • Device Class
    2
  • Implanted device?
    No
  • Distribution
    US Nationwide Distribution in the states of IL, IN, LA, OH, PA, TX & WV.
  • Product Description
    OneTray Sealed Sterilization Containers || Product Usage: || A rigid sterilization container used to steam sterilize medical devices
  • Manufacturer

Manufacturer

  • Manufacturer Address
    Innovative Sterlization Technologies LLC, 7625 Paragon Rd Ste A, Dayton OH 45459-4063
  • Source
    USFDA