Events

Safety Alert Or Field Safety Notices for Suction catheters, gastro-enteral tubes, intermittent urology catheters and sterile urine drainage bags

According to Medicines and Healthcare products Regulatory Agency, this safety alert or field safety notices involved a device in United Kingdom that was produced by ConvaTec Limited.

What is this?

Field safety notices are communications sent out by medical device manufacturers or their representatives in relation to actions that they may be taking in relation to their product that is on the market. These are mainly for health workers, but also for users. They can include recalls and alerts.

Learn more about the data here
  • Type of Event
    Safety alert / Field Safety Notice
  • Date
    2018-11-14
  • Event Date Posted
    2018-11-14
  • Event Country
    United Kingdom
  • Event Source
    MHRA
  • Event Source URL
    https://www.gov.uk//drug-device-alerts/suction-catheters-gastro-enteral-tubes-intermittent-urology-catheters-and-sterile-urine-drainage-bags-potential-breach-in-sterile-barrier-packaging-mda-2018-034
  • Notes / Alerts
    Data from the United Kingdom is current through April 2019. All of the data comes from the Medicines and Healthcare products Regulatory Agency, 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 recall data from the U.S. and the United Kingdom.
  • Extra notes in the data
  • Reason
    Manufactured by convatec limited – use of affected devices may increase risk of patients getting infections.
  • Action
    Refer to the manufacturer’s Field Safety Notice FSN for a list of affected product codes and affected lots. Stop using and quarantine affected devices as directed in the manufacturer’s FSN. Complete the ‘Recall Response Form for END USERS’ in the FSN and return to convatecproductrecall@stericycle.com to arrange return of affected device(s). Report any incidents or complaints involving this product to unomedical-uk.customerservice@convatec.com.

Device

Suction catheters, gastro-enteral tubes, intermittent urology catheters and sterile urine drainag...
  • Model / Serial
  • Product Description
    Affected devices can only be identified by comparing product code and manufacture date stated on the packaging to the product list in the manufacturer’s FSN. The breach in the packaging is not visible.In addition to the FSN, which details the affected products, please refer to the spreadsheet which accompanies this MDA for additional unique device identification information and national supply chain codes (where available).
  • Manufacturer
    ConvaTec Limited

Manufacturer

ConvaTec Limited
  • Manufacturer Address
    ConvaTec Limited Tel: 01244 832206 Email: convatecproductrecall@stericycle.com, unomedical-uk.customerservice@convatec.com.
  • Manufacturer Parent Company (2017)
    Triona Holding Sa
  • Source
    MHRA