Events

Recall of Device Recall Sterilization Wrap

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

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
    79100
  • Event Risk Class
    Class 2
  • Event Number
    Z-0753-2018
  • Event Initiated Date
    2017-06-15
  • Event Status
    Terminated
  • Event Country
    United States
  • Event Terminated Date
    2018-07-17
  • Event Source
    USFDA
  • Event Source URL
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=161352
  • 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
    Wrap, sterilization - Product Code FRG
  • Reason
    On june 15, 2017, steris identified that the purple ink located on the outside label of vis-u-all pouches may migrate following steam processing causing cosmetic defects on the exterior of the pouch and in some instances, transference of the ink onto the device(s) contained within the pouch.
  • Action
    Steris sent an Urgent Voluntary Recall Notice letter dated July 2017 to their customers. The letter identified the affected product, problem and actions to be taken. Customers were instructed to immediately inspect on-hand inventory for recalled product. If you have product in your possession, please quarantine it and contact firm to coordinate shipment of replacement product. If you have questions regarding this matter, please contact STERIS Customer Service at 1-800-548-4873.

Device

Device Recall Sterilization Wrap
  • Model / Serial
    Model# 883122 Lot# 161120A
  • Product Classification
    General Hospital and Personal Use Devices
  • Device Class
    2
  • Implanted device?
    No
  • Distribution
    US Nationwide Distribution
  • Product Description
    Vis-U-All High Temp 18"x22" Heat Seal Pouch 100 pouches per box; 5 boxes per case || Product Usage: || The Vis-U-All High Temperature Sterilization Pouch is suitable for use by healthcare providers to enclose and seal medical devices to be sterilized by steam. The pouch is designed to maintain sterility of properly processed medical devices during normal handling and storage until the pouch is opened and the medical device is removed for use.
  • Manufacturer
    Steris Corporation

Manufacturer

Steris Corporation
  • Manufacturer Address
    Steris Corporation, 5960 Heisley Rd, Mentor OH 44060-1834
  • Manufacturer Parent Company (2017)
    Steris Corporation
  • Source
    USFDA