Events

Recall of Mallinckrodt Launcher Guiding Catheter

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

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
    73835
  • Event Risk Class
    Class 2
  • Event Number
    Z-1626-2016
  • Event Initiated Date
    2016-04-04
  • Event Status
    Terminated
  • Event Country
    United States
  • Event Terminated Date
    2016-07-13
  • Event Source
    USFDA
  • Event Source URL
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=145080
  • 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
    Tube, tracheal (w/wo connector) - Product Code BTR
  • Reason
    Device packaging may not be sealed.
  • Action
    Customer notification letter was sent 04/04/2016. The customer was provided the following instructions: Use of the affected lots of the recalled product should be discontinued. A Recall Effectiveness Check Form has been enclosed. Note that the recall is limited to the specific lot number shipped to facility. Once inventory has been checked complete the Recall Effectiveness Check Form. The form needs to be completed even if no affected product is found. Return the completed and signed Recall Effectiveness Check Form utilizing one of the following methods: Return to your local Stryker Sustainability Sales Representative Email to ssspfa@stryker.com, or Mail to: Stryker Sustainability Solutions 181 O West Drake Drive Tempe, AZ. 85283 Attn: Jodie Rueckert If the form indicates that any affected devices remain in inventory, a prepaid shipping label will be issued for the return of the product. Customers will receive a credit for all affected devices returned. Adverse reactions or quality problems experienced with the use of this product may be reported to: Stryker Sustainability Solutions Complaint Hotline: +1(888) 888-3433x5555 http://www.stryker.com/productexperience/ The FDA's MedWatch Adverse Event Reporting program either online, by regular mail, or by fax.

Device

Mallinckrodt Launcher Guiding Catheter
  • Model / Serial
    Lot #481938U
  • Product Classification
    Anesthesiology Devices
  • Device Class
    2
  • Implanted device?
    No
  • Distribution
    US distribution to KY.
  • Product Description
    Launcher Guiding Catheter || Model #LA6EBU30. Used in the coronary or peripheral vascular system..
  • Manufacturer
    Stryker Sustainability Solutions

Manufacturer

Stryker Sustainability Solutions
  • Manufacturer Address
    Stryker Sustainability Solutions, 1810 W Drake Dr, Tempe AZ 85283-4327
  • Manufacturer Parent Company (2017)
    Stryker
  • Source
    USFDA