Events

Recall of Device Recall CooperSurgical

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

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
    33940
  • Event Risk Class
    Class 2
  • Event Number
    Z-0401-06
  • Event Initiated Date
    2005-11-01
  • Event Date Posted
    2006-01-18
  • Event Status
    Terminated
  • Event Country
    United States
  • Event Terminated Date
    2012-05-14
  • Event Source
    USFDA
  • Event Source URL
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=42767
  • 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
    Syringe, Piston - Product Code FMF
  • Reason
    Potential for the plunger to separate from the piston.
  • Action
    CooperSurgical notified consignees by telephone and follow-up letter dated 11/3/05 via fax. Accounts are requested to discontinue use and return inventory.

Device

Device Recall CooperSurgical
  • Model / Serial
    Lot number: 39608 Exp. Date April 08
  • Product Classification
    General Hospital and Personal Use Devices
  • Device Class
    2
  • Implanted device?
    No
  • Distribution
    CA, CO, HI, IL, MA, NH, PA, VA, WA Foreign: Canada
  • Product Description
    Milex 60cc Handy-Vak Locking Syringe || Ref: MX500
  • Manufacturer
    CooperSurgical, Inc.

Manufacturer

CooperSurgical, Inc.
  • Manufacturer Address
    CooperSurgical, Inc., 95 Corporate Drive, Trumbull CT 06611-1350
  • Source
    USFDA