Events

Recall of Cysto Pack contains Devon Light Glove

According to U.S. Food and Drug Administration, this recall involved a device in United States that was produced by Stradis Healthcare, 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
    71130
  • Event Risk Class
    Class 2
  • Event Number
    Z-2032-2015
  • Event Initiated Date
    2015-04-20
  • Event Date Posted
    2015-07-07
  • Event Status
    Completed
  • Event Country
    United States
  • Event Source
    USFDA
  • Event Source URL
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=137434
  • 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
    General surgery tray (kit) - Product Code LRO
  • Reason
    Convenience kits being recalled due to the recall by the manufacturer (medtronic) of a component (devon light glove) contained in the kits.
  • Action
    Medtronic sent an Urgent Medical Device Recall letter dated April 16, 2015, to all affected customers. The letter identified the product, the problem, and the action to be taken by the customer. Customers were instructed to quarantine and discontinue use of the affected device. Complete the Recalled Product Return Form and fax to 800-895-6140 or email to feedback.customerservice@Covidien.com. Customers with questions regarding return of the product should call 1-727-642--4124.

Device

Cysto Pack contains Devon Light Glove
  • Model / Serial
    Pack 888-2492
  • Product Classification
    General and Plastic Surgery Devices
  • Device Class
    2
  • Implanted device?
    No
  • Distribution
    Distribution US nationwide to AL, AK, CA, DE, FL, GA, HI, ID, IL, IN, KS, KY, ME, MD, MA, MI, MS, MO, NM, NJ, NY, NC, OH, OK, OR, PA, RI, SC, TN, TX, UT, VA, WA; Canada and Dubai
  • Product Description
    Cysto Pack - contains Devon Light Glove || Used during surgery
  • Manufacturer
    Stradis Healthcare, LLC.

Manufacturer

Stradis Healthcare, LLC.
  • Manufacturer Address
    Stradis Healthcare, LLC., 805 Marathon Pkwy Ste 100, Lawrenceville GA 30046-2885
  • Manufacturer Parent Company (2017)
    Stradis Healthcare
  • Source
    USFDA