Medical device manufacturer, Baxter Healthcare Ltd, has issued a medical device safety alert concerning the Irrigation Sets [Product Codes: 2C4013 & 2C4030]. The product description and lot numbers affected are detailed as below:-

• 2C4013—Four Lead TUR Irrigation Set for use with UROMATIC Plastic Containers
  • All Lot starting with UR171264 to UR385534 and starting with UR07J19029 to UR13C08036
• 2C4030—Two Lead Arthroscopic Irrigation Set for user with ARTHROMATIC Plastic Containers,
  • All Lots starting with R06K01083 to R12FO9087.

The manufacturer is issuing a voluntary recall for the Irrigation Sets listed above. An internal investigation led to discovery of pinhole defects in the packaging of the two codes listed above. These pinholes are not likely to be detected by the end user prior to use. Pinholes could compromise the sterile barrier properties of the packaging. A potential outcome of a breach in sterile packaging is contamination of the surgical field, which may lead to patient infection.

The manufacturer requests users to immediately locate, segregate and discontinue use of the affected products.

According to the local supplier, the affected products were distributed in Hong Kong.

If you are in possession of the affected products, please contact your supplier for necessary actions.

Posted on 14 May 2013