Events

Recall of Device Recall Zurpaz(TM) MEDIUM CURL, SYMMETRIC CURVE, Steerable Sheath

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

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
    77406
  • Event Risk Class
    Class 2
  • Event Number
    Z-2532-2017
  • Event Initiated Date
    2017-05-22
  • Event Status
    Terminated
  • Event Country
    United States
  • Event Terminated Date
    2018-05-29
  • Event Source
    USFDA
  • Event Source URL
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=156016
  • 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
    Lack of sterility assurance.
  • Action
    The firm notified their sole consignee by email on 05/22/2017 requesting all lots of product be recalled.

Device

Device Recall Zurpaz(TM) MEDIUM CURL, SYMMETRIC CURVE, Steerable Sheath
  • Model / Serial
    Lot # 384797
  • Product Classification
    Cardiovascular Devices
  • Device Class
    2
  • Implanted device?
    No
  • Distribution
    Distributed in MA.
  • Product Description
    Boston Scientific Zurpaz(TM) MEDIUM CURL, ASYMMETRIC CURVE, Steerable Sheath, 8.5F (2.83mm), REF Catalog No M004EPTMCA85300
  • Manufacturer
    Creganna Medical Devices

Manufacturer

Creganna Medical Devices
  • Manufacturer Address
    Creganna Medical Devices, Parkmore West, Galway Ireland
  • Manufacturer Parent Company (2017)
    TE Connectivity Ltd.
  • Source
    USFDA