Events

Recall of Device Recall Magic3 Hydrophilic 10 French Pediatric Length

According to U.S. Food and Drug Administration, this recall involved a device in United States that was produced by Rochester Medical Corp.

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
    51205
  • Event Risk Class
    Class 2
  • Event Number
    Z-1080-2009
  • Event Initiated Date
    2009-01-14
  • Event Date Posted
    2009-03-16
  • Event Status
    Terminated
  • Event Country
    United States
  • Event Terminated Date
    2011-04-20
  • Event Source
    USFDA
  • Event Source URL
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=79167
  • 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
    Urological Catheter - Product Code KOD
  • Reason
    Rochester medical observed some magic3 and hydrosil(r) catheter packages in which the catheter was caught in the package seal during the packaging process.
  • Action
    Consignees were contacted by telephone or in-person visit. The communication provided the reason for the recall and a list of affected products and their lot numbers, and instruction for the removal. Distributors were given instructions to notify their customers in turn. For the customers that were not reached via telephone call or in-person, a letter, "Voluntary recall of magic product samples," was used for the recipients of product samples and sent via e-mail. The letter was dated January 14, 2009 and asked customers to destroy all of their remaining sample inventory of the affected lot numbers.

Device

Device Recall Magic3 Hydrophilic 10 French Pediatric Length
  • Model / Serial
    Lot # 53606898
  • Product Classification
    Gastroenterology-Urology Devices
  • Device Class
    2
  • Implanted device?
    No
  • Distribution
    Worldwide Distribution -- USA including states of CA, FL, GA, ID, IL, LA, MD, MA, MI, MN, NJ, NM, NY, OH, PA, and WA and countries of United Kingdom.
  • Product Description
    Magic3 (Intermittent Catheter), Sterile. Hydrophilic 10 French Pediatric Length REF 52610 || Rochester Medical, Rochester Medical Corporation, Stewartville, MN 55976. || Intended for use for bladder management including urine drainage, collection and measurement.
  • Manufacturer
    Rochester Medical Corp

Manufacturer

Rochester Medical Corp
  • Manufacturer Address
    Rochester Medical Corp, 1 Rochester Medical Dr Nw, Stewartville MN 55976-1647
  • Source
    USFDA