Events

Recall of Vygon

According to U.S. Food and Drug Administration, this recall involved a device in United States that was produced by Vygon MFG, Inc., dba/ Churchill Medical Systems, 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
    79318
  • Event Risk Class
    Class 2
  • Event Number
    Z-0933-2018
  • Event Initiated Date
    2017-10-03
  • Event Status
    Open, Classified
  • Event Country
    United States
  • Event Source
    USFDA
  • Event Source URL
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=161870
  • 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
    I.V. start kit - Product Code LRS
  • Reason
    The iodine prep pads within the vygon iv start convenience kits, had stability samples that were not meeting iodine assay level requirements to support the 36 month expiration date. all kits containing the affected pads were recalled.
  • Action
    Vygon sent an Urgent Medical Device Recall letter dated October 3, 2017. Customers requested to check stock and quarantine affected devices and to complete Recall Acknowledgement and Inventory Return Form. Customers instructed to fax or email the form to Vygon including customer contact info. Vygon will contact the customer and issue a Return Merchandise Authorization Number. Distributors instructed to communicate recall to customers who received affected product and provide them copy of the recall notification. Returned products were received in Lansdale, PA warehouse location and placed into quarantine. For further questions, please call Customer Service at (800) 473-5414.

Device

Vygon
  • Model / Serial
    AMS-623T-6 (1506075D, 1508057D, 1511030D, 1604024D, 1605080D, 1610017D, 1706097D, 1707055D) and AMS-626TGSLF (1601102D, 1603099D, 160581D, 1607019D, 1610057D, 1703068D, 1703069D, 1704065d, 1706076D, 1707031d, 1707056D)
  • Product Classification
    General and Plastic Surgery Devices
  • Device Class
    2
  • Implanted device?
    No
  • Distribution
    US Distribution.
  • Product Description
    Vygon IV Start Convenience Kits; Product Codes AMS-623T and AMS-626TGSLF. || Kit used when administering IV during emergency.
  • Manufacturer
    Vygon MFG, Inc., dba/ Churchill Medical Systems, Inc.

Manufacturer

Vygon MFG, Inc., dba/ Churchill Medical Systems, Inc.
  • Manufacturer Address
    Vygon MFG, Inc., dba/ Churchill Medical Systems, Inc., 87 Venture Dr, Dover NH 03820-5914
  • Manufacturer Parent Company (2017)
    Soc Part Financiere Pierre Simonet
  • Source
    USFDA