Events

Recall of Blunt Hurd CannulaBlunt Tip 10mm with 5mm Reducer

According to U.S. Food and Drug Administration, this recall involved a device in United States that was produced by CooperSurgical, Inc. D.B.A. Lone Star Medical Products.

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
    69446
  • Event Risk Class
    Class 2
  • Event Number
    Z-0147-2015
  • Event Initiated Date
    2013-09-13
  • Event Date Posted
    2014-10-29
  • Event Status
    Terminated
  • Event Country
    United States
  • Event Terminated Date
    2015-09-23
  • Event Source
    USFDA
  • Event Source URL
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=130631
  • 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
    Trocar - Product Code DRC
  • Reason
    Coopersurgical is recalling two lots of 900-863 because the wrong package insert (ifu) was placed into the shipper.
  • Action
    CooperSurgical sent an Urgent Field Safety Notice ( Correction ) dated September 27, 2013, to all affected customers. The letter identified the product the problem and the action needed to be taken by the customer. The recalling firm provided correct package inserts (IFU) to affected consignees. The recalling firm intends to conduct effectiveness checks by reviewing return receipts from the initial recall communication. We apologize for any inconvenience this communication may cause. If you have any questions or concerns, please contact CooperSurgical at (203) 601-9818.

Device

Blunt Hurd CannulaBlunt Tip 10mm with 5mm Reducer
  • Model / Serial
    Lots 149460 and 149911
  • Product Classification
    Cardiovascular Devices
  • Device Class
    2
  • Implanted device?
    No
  • Distribution
    Worldwide Distribution: US (nationwide) to North Carolina; and Internationally to Australia and Italy.
  • Product Description
    Blunt Hurd Cannula Blunt Tip 10 mm with 5 mm Reducer simplifies open laparoscopy.
  • Manufacturer
    CooperSurgical, Inc. D.B.A. Lone Star Medical Products

Manufacturer

CooperSurgical, Inc. D.B.A. Lone Star Medical Products
  • Manufacturer Address
    CooperSurgical, Inc. D.B.A. Lone Star Medical Products, 11211 Cash Rd, Stafford TX 77477-4310
  • Manufacturer Parent Company (2017)
    The Cooper Companies, Inc.
  • Source
    USFDA