Recall of Device Recall CIVCO SurgiTip Transducer cover

According to U.S. Food and Drug Administration, this recall involved a device in United States that was produced by Civco Medical Instruments 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
  • Event ID
  • Event Risk Class
    Class 2
  • Event Number
  • Event Initiated Date
  • Event Date Posted
  • Event Status
  • Event Country
  • Event Terminated Date
  • Event Source
  • Event Source URL
  • 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
    Transducer, ultrasonic, diagnostic - Product Code ITX
  • Reason
    Polyethylene material did not have proper treatment applied during manufacturing. untreated polyethylene material does not maintain a secure seal with the adhesive tape used to secure the tip to the cover.
  • Action
    CIVCO sent a "Urgent - Medical Device Correctdion" letter date July 19, 2010 to consignees describing the reason for recall and requesting they dispose of the affect lot number of product. A response form was enclosed for completion and return to the firm, indicating the amount of product in inventory and requesting a Return Authorization Number. The form was to be returned via FAX or e-mail. Customers may contact CIVO at 800-445-6741.


  • Model / Serial
    Lot M538160
  • Product Classification
  • Device Class
  • Implanted device?
  • Distribution
    Nationwide distribution: the states of OH, MD, NE, VA, IA, MI, WA, and WI.
  • Product Description
    CIVCO Surgi-Tip Transducer Cover, Ref. 610-834, Sterile (20.3 x 244cm) polyethylene telescopically-folded cover with attached (6cm) NeoGuard tip. The latex-free surgi tipped covers are utilized to cover ultrasound transducers and prevent cross-contamination from occurring with equipment and patients.
  • Manufacturer


  • Manufacturer Address
    Civco Medical Instruments Inc, 102 1st St S, Kalona IA 52247-9589
  • Manufacturer Parent Company (2017)
  • Source