Events

Recall of Device Recall Tyvek SelfSeal Pouch with STERRAD Chemical Indicator

According to U.S. Food and Drug Administration, this recall involved a device in United States that was produced by Advanced Sterilization Products.

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
    56367
  • Event Risk Class
    Class 2
  • Event Number
    Z-1393-2011
  • Event Initiated Date
    2010-06-23
  • Event Date Posted
    2011-02-22
  • Event Status
    Terminated
  • Event Country
    United States
  • Event Terminated Date
    2012-03-14
  • Event Source
    USFDA
  • Event Source URL
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=93317
  • 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 recall was initiated after advanced sterilization products (asp) discovered a non-conforming lot. the misaligned perforations may have caused the seal to be incomplete on some of the pouches, creating a potential breach for pouches being used to store sterilized equipment on shelves.
  • Action
    Advanced Sterilization Products (ASP) released Urgent: Product Recall notifications to its consignees identifying the affected product and explaining the reason for recall. The letter also discussed the impact of using this affected product and return instructions. The firm asked customers to examine their inventory, discontinue use of Tyvek Self-Seal Pouch with STERRAD Chemical Indicator 12332 and to return all unused affected products to Stericycle. Customers are to complete the Business Reply Card and return it to Stericycle.

Device

Device Recall Tyvek SelfSeal Pouch with STERRAD Chemical Indicator
  • Model / Serial
    Lot Number: 2020
  • Product Classification
    General Hospital and Personal Use Devices
  • Device Class
    2
  • Implanted device?
    No
  • Distribution
    Worldwide Distribution -- USA, Argentina, Australia, Canada, Chile, Czech Republic, Hong Kong, India, Japan, Panama, Peru and Puerto Rico.
  • Product Description
    Tyvek Self-Seal Pouch with STERRAD Chemical Indicator 12332. || Intended to be used to contain medical devices that are being terminally sterilized in STERRAD Sterilization Systems.
  • Manufacturer
    Advanced Sterilization Products

Manufacturer

Advanced Sterilization Products
  • Manufacturer Address
    Advanced Sterilization Products, 33 Technology Drive, Irvine CA 92618
  • Manufacturer Parent Company (2017)
    Johnson & Johnson
  • Source
    USFDA