Events

Recall of Device Recall ViaSpan Cold Storage Solution 1000mL Bag

According to U.S. Food and Drug Administration, this recall involved a device in United States that was produced by Teva Pharmaceuticals USA, 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
    61622
  • Event Risk Class
    Class 2
  • Event Number
    Z-1437-2012
  • Event Initiated Date
    2012-03-30
  • Event Date Posted
    2012-04-18
  • Event Status
    Terminated
  • Event Country
    United States
  • Event Terminated Date
    2012-10-25
  • Event Source
    USFDA
  • Event Source URL
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=108554
  • 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
    Set, perfusion, kidney, disposable - Product Code KDL
  • Reason
    Lack of assurance of sterility.
  • Action
    Teva Pharmaceuticals USA sent an "URGENT MEDICAL DEVICE RECALL-RETAIL LEVEL" letter dated March 30, 2012. The letter identifies the problem, product, and actions to be taken by the customers. The letter instructs customers to check their inventory and to discontinue distribution of the affected product. A Stock Response Form was enclosed for customers to complete and return via fax to 817-868-5362. Contact Teva Customer Services at 800-545-8800 for questions regarding this notice.

Device

Device Recall ViaSpan Cold Storage Solution 1000mL Bag
  • Model / Serial
    Product code 1000-46-06, lot # 16EK007, exp 10/2012; and 16EK0193, exp 10/2012
  • Product Classification
    Gastroenterology-Urology Devices
  • Device Class
    2
  • Implanted device?
    No
  • Distribution
    Nationwide Distribution-USA (nationwide) including the states of AL, AZ, CA, CT, DE, FL, GA, IA, IL, KS, KY, LA, MA, MD, MN, MO, NC, ND, NE, NJ, NM, NY, OH, OR, PA, SC, SD, TN, TX, UT, VA, VT, WA, WI and WV and Washington, D.C.
  • Product Description
    ViaSpan Cold Storage Solution 1000mL Bag distributed under the Barr/Duramed Pharmaceuticals label (10 x 1000mL bags). || Disposable kidney perfusion set.
  • Manufacturer
    Teva Pharmaceuticals USA, Inc.

Manufacturer

Teva Pharmaceuticals USA, Inc.