Events

Recall of Surgidyne SVac round fluted channel silicone drain

According to U.S. Food and Drug Administration, this recall involved a device in United States that was produced by Aspen Surgical Products, 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
    51898
  • Event Risk Class
    Class 3
  • Event Number
    Z-1638-2009
  • Event Initiated Date
    2009-04-13
  • Event Date Posted
    2009-05-22
  • Event Status
    Terminated
  • Event Country
    United States
  • Event Terminated Date
    2009-11-23
  • Event Source
    USFDA
  • Event Source URL
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=81606
  • 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
    Surgidyne S-Vac round fluted channel silicone drain - Product Code GCY
  • Reason
    An adaptor, which may be required when connecting the drain to an external device, was not included in the package.
  • Action
    An "Urgent Medical Device recall" letter dated April 13, 2009 was issued to consignees via certified mail. The letter described the affected product. and actions for customers. Consignees were instructed to carry out the recall to the retail level and to quarantine and return the product to Aspen Surgical Products, Inc. Consignees were also instructed to complete the enclosed response form and return it via mail, fax or e-mail. Direct questions about the recall by calling Aspen Surgical Products, Inc. at 1-616-698-7100, extension 142 or extension 141.

Device

Surgidyne SVac round fluted channel silicone drain
  • Model / Serial
    Lot Number 2014-02-13.
  • Product Classification
    General and Plastic Surgery Devices
  • Device Class
    1
  • Implanted device?
    No
  • Distribution
    Nationwide Distribution -- California, Florida, Georgia, Massachusetts and Missouri.
  • Product Description
    Surgidyne S-Vac round fluted channel silicone drain, 1/8" trocar, 10 FR, round, full fluted, 28 cm length, 4 channel, contains 10, sterile, Sterion Inc., Ham Lake, MN; REF 332187. || The device is a sterile, portable closed system designed to evacuate post-operative wound drainage and promote healing.
  • Manufacturer
    Aspen Surgical Products, Inc.

Manufacturer

Aspen Surgical Products, Inc.
  • Manufacturer Address
    Aspen Surgical Products, Inc., 6945 Southbelt Dr Se, Caledonia MI 49316-7664
  • Manufacturer Parent Company (2017)
    Hill-Rom Holdings, Inc
  • Source
    USFDA