Events

Recall of Prism Healthcare A CooperSurgical Company

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
    29970
  • Event Risk Class
    Class 3
  • Event Number
    Z-0005-05
  • Event Initiated Date
    2004-08-17
  • Event Date Posted
    2004-10-05
  • Event Status
    Terminated
  • Event Country
    United States
  • Event Terminated Date
    2012-05-10
  • Event Source
    USFDA
  • Event Source URL
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=34888
  • 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
    Extractor, Vacuum, Fetal - Product Code HDB
  • Reason
    Product is mislabeled as a mushroom cap vacuum but actually contains a bell style assisted delivery system.
  • Action
    CooperSurgical telephoned consignees on 8/18/04 and sales representatives to visit the account for removal of recalled product.

Device

Prism Healthcare A CooperSurgical Company
  • Model / Serial
    Lot Number: 30115
  • Product Classification
    Obstetrical and Gynecological Devices
  • Device Class
    2
  • Implanted device?
    No
  • Distribution
    FL, IA, KS, GA, MA, MN, MS, NE, NY, OH, OK, VA, ME, TX, VA Foreign: Italy
  • Product Description
    Mystic M-Style Mushroom Cup Mityvac Vacuum Assisted Delivery System || Product No: 10047
  • Manufacturer
    CooperSurgical, Inc.

Manufacturer

CooperSurgical, Inc.
  • Manufacturer Address
    CooperSurgical, Inc., 95 Corporate Dr, Trumbull CT 06611-1350
  • Manufacturer Parent Company (2017)
    The Cooper Companies, Inc.
  • Source
    USFDA