Events

Recall of Biosense Webster's Reprocessed SOUNDSTAR eco Diagnostic Ultrasound Catheters

According to U.S. Food and Drug Administration, this recall involved a device in United States that was produced by STERILMED, 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
    69337
  • Event Risk Class
    Class 2
  • Event Number
    Z-0059-2015
  • Event Date Posted
    2014-10-09
  • Event Status
    Terminated
  • Event Country
    United States
  • Event Terminated Date
    2015-08-11
  • Event Source
    USFDA
  • Event Source URL
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=130259
  • 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
    Reprocessed intravascular ultrasound catheter - Product Code OWQ
  • Reason
    Sterilmed, a division of johnson & johnson medical nv/sa (sterilmed), has become aware of an issue affecting certain lots of reprocessed soundstar® eco diagnostic ultrasound catheters for which sterilmed is the reprocessor and biosense webster is the distributor. sterilmed determined that the units of these lots were incorrectly processed and as a result when the affected catheter is conne.
  • Action
    Sterilmed sent an "Field Notification" letter dated September 22, 2014, to all affected customers. The letter identified the product the problem and the action needed to be taken by the customer. Actions requested on your part: 1. Read the Description of the Problem section below carefully. 2.Immediately identify and set aside all units from the affected lots of product listed above in a manner that ensures the affected product will not be used. 3. Maintain a copy of this letter with the affected product. 4. Review, complete, sign and return the attached Field Removal Certification Form in accordance with the instructions listed on the form. 5. Arrange for return of any impacted units from the provided list of affected Reprocessed SOUNDSTAR¿ eco Diagnostic Ultrasound Catheters that you may have in your inventory per the instructions on the Field Removal Certification Form. 6. Pass on this notice to anyone in your facility that needs to be informed. 7. If any of the affected Reprocessed SOUNDSTAR¿ eco Diagnostic Ultrasound Catheters have been forwarded to another facility, contact that facility and arrange for the return. 8. Maintain awareness of this notice until all affected product with lot numbers listed above has been returned to Biosense Webster. For questions related to this issue and product return please contact your Biosense Webster sales representative. For further questions please call (763) 488-3400.

Device

Biosense Webster's Reprocessed SOUNDSTAR eco Diagnostic Ultrasound Catheters
  • Model / Serial
    Lot Numbers: 1717945, 1721574, 1721575 and 1723123  Catalog Nos: M-5723-115, Model Number BIO10438577
  • Product Classification
    Cardiovascular Devices
  • Device Class
    2
  • Implanted device?
    No
  • Distribution
    US Distribution including the states of WA and CA.
  • Product Description
    Biosense Webster's Reprocessed SOUNDSTAR¿ eco Diagnostic Ultrasound Catheters, Catalog Nos: M-5723-115, Model Number BIO10438577.
  • Manufacturer
    STERILMED, INC.

Manufacturer

STERILMED, INC.
  • Manufacturer Address
    STERILMED, INC., 11400 73rd Ave N, Maple Grove MN 55369-5561
  • Manufacturer Parent Company (2017)
    Johnson & Johnson
  • Source
    USFDA