Events

Recall of Device Recall The Fuhrman Pleural/Pneumopericardial Drainage Set

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
    72715
  • Event Risk Class
    Class 1
  • Event Number
    Z-0478-2016
  • Event Initiated Date
    2015-11-17
  • Event Date Posted
    2016-01-04
  • Event Status
    Terminated
  • Event Country
    United States
  • Event Terminated Date
    2016-09-28
  • Event Source
    USFDA
  • Event Source URL
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=142020
  • 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
    Bottle, collection, vacuum - Product Code KDQ
  • Reason
    Stryker sustainability solutions is recalling the fuhrman pleural & pneumopericardial drainage set due to receiving complaints that it broke off in the pleural cavity while inserting the device into the patient.
  • Action
    The firm, Stryker Sustainability Solutions, sent a "URGENT MEDICAL DEVICE RECALL" letter dated 11/17/2015 to its customers. The letter identified the product, problem, and actions to be taken by the customers. Customers were instructed to discontinue the use of the product, and complete the Recall Effectiveness Check Form even if no product has been found in inventory. Customers should return the completed Recall Effectiveness Check Form to their local Stryker Sustainability Sales Representative, email to ssspfa@stryker.com, or mail to: Stryker Sustainability Solutions, 1810 West Drake Drive,Tempe, AZ 85283. If the firm indicates that affected devices remain in inventory, a prepaid shipping label will be issued for the return of the product. Customers will receive 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 FDAs MedWatch Adverse Event Reporting program either online, by regular mail, or by fax. If you have any questions, contact Senior Regulatory Affairs Specialist at (888) 888-3433x5506 or email: chelsea.cullen@stryker.com.

Device

Device Recall The Fuhrman Pleural/Pneumopericardial Drainage Set
  • Model / Serial
    Item Number G03974  Lot Number 295397U 331621U 374044U 394431U 406125U 406131U 410982U 412655U 415094U 422060U 519812U 7718289U 838193U
  • Product Classification
    General Hospital and Personal Use Devices
  • Device Class
    2
  • Implanted device?
    No
  • Distribution
    US Distribution in the states of: AK, CA, WI, IN, FL, OR, NY, and NC.
  • Product Description
    The Fuhrman Pleural/Pneumopericardial Drainage Set || The Fuhrman Pleural/Pneumopericardial Drainage Set consists of pigtail catheter, access needle, dilator, and wire guide. The set also includes a multipurpose tubing adapter, and three-way stopcock.
  • Manufacturer
    Stryker Sustainability Solutions

Manufacturer

Stryker Sustainability Solutions
  • Manufacturer Address
    Stryker Sustainability Solutions, 10232 S 51st St, Phoenix AZ 85044-5205
  • Manufacturer Parent Company (2017)
    Stryker
  • Source
    USFDA