Events

Recall of Device Recall Stryker Cournand Modified 2PC 19 gauge, 5.4 centimeter guidewire introducer needles

According to U.S. Food and Drug Administration, this recall involved a device in United States that was produced by Stryker Instruments Div. of Stryker 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
    72775
  • Event Risk Class
    Class 2
  • Event Number
    Z-0417-2016
  • Event Initiated Date
    2015-11-23
  • Event Date Posted
    2015-12-14
  • Event Status
    Terminated
  • Event Country
    United States
  • Event Terminated Date
    2016-09-06
  • Event Source
    USFDA
  • Event Source URL
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=142281
  • 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
    Introducer, catheter - Product Code DYB
  • Reason
    The guidewire introducer needle (0910-192-000) was shipped after the documented expiration date or with minimal time until expiration. there is a potential risk of a soft tissue infection to the patient if device is used after expiration date.
  • Action
    Stryker sent an Urgent Medical Device Recall Notification letter dated November 24, 2015, to all affected customers via courier with instructions for identifying and returning the affected product. The recall notification included a description of the reason for the recall, affected product, consignee responsibilities, and instructions for responding to the formal recall notification. For questions regarding this recall, please contact Stryker Instruments: Monday-Friday 8am-5pm (EST) 269-389-2921

Device

Device Recall Stryker Cournand Modified 2PC 19 gauge, 5.4 centimeter guidewire introducer needles
  • Model / Serial
    Model Number(s): 0910-192-000 Lot Numbers Affected 61406007 expiration date: 8/31/2015
  • Product Classification
    Cardiovascular Devices
  • Device Class
    2
  • Implanted device?
    No
  • Distribution
    Nationwide Distribution including PA and SC.
  • Product Description
    Cournand Modified 2-PC 19G, 5.4cm or (Guidewire Introducer Needle) || 20 units per case || The Stryker Guidewire Introducer Needles are designed for the percutaneous puncture of the anterior/posterior wall of a blood vessel. This provides an entry for a guidewire, vessel dilator, sheath, and catheter introduction.
  • Manufacturer
    Stryker Instruments Div. of Stryker Corporation

Manufacturer

Stryker Instruments Div. of Stryker Corporation
  • Manufacturer Address
    Stryker Instruments Div. of Stryker Corporation, 4100 E Milham Ave, Portage MI 49002-9704
  • Manufacturer Parent Company (2017)
    Stryker
  • Source
    USFDA