Medical device manufacturer, Baxter Healthcare Ltd, has issued a medical device safety alert concerning the Coiled Tube Infusors [Product Codes: 2C1071KJP, 2C1075KJP, 2C1976KJ]. The affected products were manufactured between November 2008 through September 2009.
Due to an increase in complaints for leaks at the distal male luer and luer cap, Baxter implemented enhancements to the blue winged cap to improve the seal between the cap and the luer. Complaint rates for leaks have since decreased. Baxter wants to ensure that no affected product remains in the field.
Leakage at the connection of the blue winged cap and the distal male luer presents the potential for delay/interruption of therapy and exposure to hazardous solutions.
The manufacturer requests users to locate and return 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 05 Jun 2013