Medical device manufacturer, Bard Peripheral Vascular, Inc., has issued a medical device safety alert concerning its Bard TruGuide disposable Coaxial biopsy needles [Part number: C2016B, Lot numbers: REWL0924, REXA1695, REXB1529, REXC1632].
The manufacturer has confirmed that the product code/ lot number combination listed above may be at risk of having an incorrectly sized blunt tip stylet within its packaging that will not pass through the coaxial. Specifically, the product should contain a 19 gauge blunt tip stylet when the actual packaged product contains a 17 gauge blunt tip stylet.
According to the manufacturer, the potential hazard associated with attempting to proceed in the placement of the coaxial utilising the sharp trocar stylet, instead of the intended optional blunt tip stylet, may be variable depending on the anatomical location of the biopsy and may pose an incremental risk of unintended injury to tissue, vasculature, or other organs. If the affected device has already been safely used, then no further product related action is required.
Product recall is on-going.
According to the local supplier, the affected products are not distributed in Hong Kong.
If you are in possession of the affected products, please contact your supplier for necessary actions.
Posted on 15 February 2016