Events

Recall of Device Recall CROSSCHECKS P plasma sterilization indicator

According to U.S. Food and Drug Administration, this recall involved a device in United States that was produced by Steritec Products Mfc. Co., 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
    52777
  • Event Risk Class
    Class 2
  • Event Number
    Z-1531-2010
  • Event Initiated Date
    2009-07-15
  • Event Date Posted
    2010-04-29
  • Event Status
    Terminated
  • Event Country
    United States
  • Event Terminated Date
    2010-06-28
  • Event Source
    USFDA
  • Event Source URL
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=83980
  • 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
    Plasma and steam sterilization indicators - Product Code JOJ
  • Reason
    This action notifies affected steritec customers as well as private label distributors of the necessity to modify the shelf life of their sterilization indicator products. there is insufficient data on file to support the shelf life dating on the product labeling.
  • Action
    Notify accounts by e-mail and letter, offering to exchange product for product with revised expiration date. Products exhausted by proper expiration date need not be returned or relabeled. Questions are directed to the firm at (303) 660-4201.

Device

Device Recall CROSSCHECKS P plasma sterilization indicator
  • Model / Serial
    Lot numbers: 061001, 061101, 070201, 070401, 070601, 070701, 080101, 080801, 080901, 081001, 0900201, 090301, 090401, 090402
  • Product Classification
    General Hospital and Personal Use Devices
  • Device Class
    2
  • Implanted device?
    No
  • Distribution
    Nationwide distribution: IL, MI, NY, OH, VA
  • Product Description
    Violet Ink sterilization indicators Violet Ink (Class 6) and Violet Ink (Bowie Dick). Product numbers: CI 144, BD 115, PL 315, PL319, PL232, PL236, PL237, PL 238.
  • Manufacturer
    Steritec Products Mfc. Co., Inc.

Manufacturer

Steritec Products Mfc. Co., Inc.
  • Manufacturer Address
    Steritec Products Mfc. Co., Inc., 74 Inverness Dr E, Englewood CO 80112-5114
  • Manufacturer Parent Company (2017)
    Steritec Product Mfg. Co. Inc.
  • Source
    USFDA