Events

Safety Alert for TISSUE-GUARD Family of Products - VASCU-GUARD, DURA-GUARD, PERI-GUARD and SUPPLE PERI-GUARD

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

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
    2013-10-16
  • Event Date Posted
    2013-10-16
  • Event Country
    Hong Kong
  • Event Source
    DH
  • Event Source URL
    https://www.mdco.gov.hk/english/safety/recalls/recalls_20131016d.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: baxter tissue-guard family of products - vascu-guard, dura-guard, peri-guard and supple peri-guard medical device manufacturer, baxter, has issued a field safety notice concerning tissue-guard family of products - vascu-guard, dura-guard, peri-guard and supple peri-guard. the affected products can be identified as follows: product code: pc-0608nsp product description: peri-guard, 6x8 cm the affected lot serial numbers: spce113-04d0044, spce113-04d0102, spce113-07g0048, spce113-feb0079 and spce113-jan0118 it has been determined that specific shipping configurations in which more than eight 6 ounce units are shipped together with a specific revision of the instructions for use can place pressure on the package, which can lead to damage and leakage. there are no reports of patient involvement or any known adverse events associated with this issue. improvements to the packing and shipping processes have been implemented to help eliminate this issue. the manufacturer advises users to discontinue use of the affected products and return them to baxter for replacement. according to the local supplier, the affected products were distributed in hong kong. if you are in possession of the product, please contact your supplier for necessary actions. posted on 16 october 2013.

Device

TISSUE-GUARD Family of Products - VASCU-GUARD, DURA-GUARD, PERI-GUARD and SUPPLE PERI-GUARD
  • Model / Serial
  • Product Description
    Medical Device Safety Alert: Baxter TISSUE-GUARD Family of Products - VASCU-GUARD, DURA-GUARD, PERI-GUARD and SUPPLE PERI-GUARD
  • Manufacturer
    Baxter

Manufacturer

Baxter