Events

Recall of McKesson MediPak Vaginal Speculum, 10/bag, Reorder No. 118309

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
    71313
  • Event Risk Class
    Class 2
  • Event Number
    Z-1824-2015
  • Event Initiated Date
    2015-04-13
  • Event Date Posted
    2015-06-22
  • Event Status
    Terminated
  • Event Country
    United States
  • Event Terminated Date
    2016-02-05
  • Event Source
    USFDA
  • Event Source URL
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=137298
  • 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
    Speculum, vaginal, nonmetal - Product Code HIB
  • Reason
    Small sized specula were incorrectly packaged in printed bags for the medium sized speculum.
  • Action
    CooperSurgical sent an Urget Medical Device Recall letter dated April 13, 2015, to all affected customers. The letter identified the product, the problem, and the actions to be taken by the customer. Customers were instructed to discontinue use, discard, or return the affected to product to Cooper Surgical. Customers were asked to complete the attached Acknowledgment and Receipt Form for replacement. Customers with questions were instructed to call 203-601-5200.

Device

McKesson MediPak Vaginal Speculum, 10/bag, Reorder No. 118309
  • Model / Serial
    Work Order:164290
  • Product Classification
    Obstetrical and Gynecological Devices
  • Device Class
    2
  • Implanted device?
    No
  • Distribution
    Nationwide Distribution including IL, FL, GA, MA, MO, TX, and WA.
  • Product Description
    McKesson Medi-Pak Vaginal Speculum, 10/bag || Reorder No. 11-8309 || Used to expose interior of the vagina to facilitate visualization during gynecological and obstetrical procedures
  • Manufacturer
    CooperSurgical, Inc.

Manufacturer

CooperSurgical, Inc.
  • Manufacturer Address
    CooperSurgical, Inc., 75 Corporate Dr, Trumbull CT 06611-1350
  • Manufacturer Parent Company (2017)
    The Cooper Companies, Inc.
  • Source
    USFDA