Events

Recall of Device Recall CIVCO SurgiTip Transducer Cover, REF 610833

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
    Recall
  • Event ID
    70719
  • Event Risk Class
    Class 2
  • Event Number
    Z-1400-2015
  • Event Initiated Date
    2015-02-26
  • Event Date Posted
    2015-04-08
  • Event Status
    Terminated
  • Event Country
    United States
  • Event Terminated Date
    2017-02-28
  • Event Source
    USFDA
  • Event Source URL
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=134563
  • 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
    Leaks were detected in the recalled lot which may compromise the sterility of the product.
  • Action
    On 3/12/2015, the Urgent Medical Device Recall notice was emailed to all of the affected customers. The notice identified the affected product and stated that the sterile covers from the affected manufacturing lot were not meeting quality levels and may leak. Customers were requested to return all of surgi tip covers from the production lot identified for replacement. To schedule the return and arrange for replacement product to be sent, customers were asked to contact Ms. Amy King, Customer Service Team Leader at 319-248-6520 or info@civco.com.

Device

Device Recall CIVCO SurgiTip Transducer Cover, REF 610833
  • Model / Serial
    Tyvek pouch - lot M591280; Box lot - M612600 Expiration date 2018.01
  • Product Classification
    Radiology Devices
  • Device Class
    2
  • Implanted device?
    No
  • Distribution
    Distributed to the states of CA, IL, MA, MI, MO, and WI.
  • Product Description
    CIVCO Surgi-Tip Transducer Cover Sterile (15.2 x 244 cm) polyethylene telescopically-folded cover with attached (3 cm) NeoGuard tip, REF 610-833. Each cover is packaged in a Tyvek pouch with accessories of gel and fasteners. Individual Tyvek pouches are packaged as a box of 12. Rx only. || The cover allows use of the transducer in scanning and needle guided procedures for body surface, endocavity and intra-operative diagnostic ultrasound.
  • Manufacturer
    Civco Medical Instruments Inc

Manufacturer

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