Events

Recall of Device Recall Sleek OTWREF 4261201XInflated Balloon

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

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
    62927
  • Event Risk Class
    Class 2
  • Event Number
    Z-2441-2012
  • Event Initiated Date
    2011-01-31
  • Event Date Posted
    2012-09-21
  • Event Status
    Terminated
  • Event Country
    United States
  • Event Terminated Date
    2013-11-26
  • Event Source
    USFDA
  • Event Source URL
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=112185
  • 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
    Catheters, transluminal coronary angioplasty, percutaneous - Product Code LOX
  • Reason
    On 1/20/2011 cordis corporation , miami lakes, fl initiated a recall of their sleek otw pta dilatation catheter model #4261201x lot #50027149 and model #4261501x lot #50026688. product is incorrectly labeled.
  • Action
    Cordis (Johnson & Johnson Company) sent an Urgent Medical Device Field Corrective Action Notice dated January 31, 2011, to all affected customers. The letter identified the product, the problem, and the action to be taken by the customer. Customers were instructed to review, sign, and return the enclosed Acknowledgment Form directly to Cordis at the fax number on the form, or to their local sales representative. Pass the revised labeling notice to all who need to be aware within their facility or organization. Also, customers were asked to maintain awareness of this notice until all affected product in their facility has been consumed. In addition to their local Cordis representative, they may contact the normal HCS Customer Service number at 1-800-327-7714, option 1, option 3. For questions regarding this recall call 786-313-2365.

Device

Device Recall Sleek OTWREF 4261201XInflated Balloon
  • Model / Serial
    Lot #50027149
  • Product Classification
    Cardiovascular Devices
  • Device Class
    2
  • Implanted device?
    No
  • Distribution
    Worldwide Distribution - USA and Germany
  • Product Description
    Sleek OTW***REF 426-1201X***Inflated Balloon Dia/mm***1.25***Inflated Balloon Length/mm***15***Usable Catheter Length/cm***150*** Lot 50027149***2013-09***Cordis*** Sleek***OTW***REF Cat. No. 426-1201X***PTA Dilatation Catheter***Cordis***Johnson Johnson Company***LOT Lot No. 50027149***Use by 2013-09***Sterile***EO***Method of Sterilization: ETO***ClearStream***Clearstream Technologies, Ltd.***Moyne Upper, Enniscorthy Co Wexford, Ireland***Phone: +353-53-92-37111***Fax: +353-53-92-37-100***Made in Ireland***Distributed by: Cordis Cashel***Cahir Road, Cashel, Co. Tipperary, Ireland***Tel: +353--(0)62-70000. || The SLEEK OTW Percutaneous Transluminal Angioplasty (PTA) Peripheral Catheter Family is a non-reusable semi-compliant coaxial design catheter with a balloon mounted on its distal tip. The hub/"Y" connector consists of a through lumen, allowing the catheter to track over a guidewire, and a balloon port, used to inflate the balloon. The catheter shaft is small beneath the balloon achieve low profile. The distal tip is further tapered to accept the appropriate guidewire. Platinum iridium bands serve to locate the balloon under fluoroscopy. A 0.014" (0.356 mm) guidewire is recommended for use with the SLEEK OTW Catheter.
  • Manufacturer
    Cordis Corporation

Manufacturer

Cordis Corporation
  • Manufacturer Address
    Cordis Corporation, 14201 Nw 60th Ave, Miami Lakes FL 33014-2802
  • Manufacturer Parent Company (2017)
    Cardinal Health
  • Source
    USFDA