Events

Safety Alert for SINGLE-USE CPO-6 COLPO-PNEUMO OCCLUDER

According to Department of Health, this safety alert involved a device in Hong Kong that was produced by CooperSurgical.

What is this?

Alerts provide important information and recommendations about products. Even though an alert has been issued, it does not necessarily mean a product is considered to be unsafe. Safety Alerts, addressed to health workers and users, may include recalls. They can be written by manufacturers, but also by health officials.

Learn more about the data here
  • Type of Event
    Safety alert
  • Date
    2018-09-14
  • Event Date Posted
    2018-09-14
  • Event Country
    Hong Kong
  • Event Source
    DH
  • Event Source URL
    https://www.mdco.gov.hk/english/safety/recalls/recalls_20180914.html
  • Notes / Alerts
    Hong Kong data is current through September 2018. All of the data comes from the Department of Health (Hong Kong), except for the categories Manufacturer Parent Company and Product Classification.
    The Parent Company and the Product Classification were added by ICIJ.
    The parent company information is based on 2017 public records. The device classification information comes from FDA’s Product Classification by Review Panel, based on matches of data from the U.S. and Hong Kong.
  • Extra notes in the data
    Medical Device Safety Alert
  • Reason
    Medical device safety alert: coopersurgical single-use cpo-6 colpo-pneumo occluder medical device manufacturer, coopersurgical, has issued a medical device safety alert concerning its single-use cpo-6 colpo-pneumo occluder [part number: cpo-6; lot numbers: 244131, 244132, 244670, 244671, 244887, 244888, 244889, 244890, 245228, 245325, 245326, 245327, 245613, 245614, 245615, 245976, 245977, 245978, 245979, 246810, 246811, 247262, 247608, 247609, 247610, & 248112] the manufacturer is recalling 26 lots of the affected product due to the possibility that the seal of the sterile pouch may be compromised, thereby increasing the risk of infection. this condition was detected during a complaint investigation unrelated to the packaging seal. there have not been any adverse events reported to coopersurgical due to this potential issue. the manufacturer has initiated a corrective action to inspect finished goods in inventory for potential unsealed pouches. according to the manufacturer, a product is acceptable for use if it is visually confirmed that the pouch’s seal is intact. as indicated in the directions for use, each package should be handled with care and inspected for damage, including the seal area before use. the affected users are advised to inspect the package contents and the sterile seal along the entire periphery of the package. they should discontinue use of the product with any packaging irregularities and quarantine the product, product replacement is on-going. according to the manufacturer, the affected products are distributed in hong kong. if you are in possession of the products, please contact your supplier for necessary actions. posted on 14 september 2018.

Device

SINGLE-USE CPO-6 COLPO-PNEUMO OCCLUDER
  • Model / Serial
  • Product Description
    Medical Device Safety Alert: CooperSurgical SINGLE-USE CPO-6 COLPO-PNEUMO OCCLUDER
  • Manufacturer
    CooperSurgical

Manufacturer

CooperSurgical