CanadaBard Marquee 12g x 10 cm disposable core biopsy instruments (model MQ1210, lots 0001618258 and 0001633216) are affected. They were recalled because some needles may have been manufactured without the backend notch retention feature, which can result in inadequate securing of the needle inside the device; contact the manufacturer for additional information.
What's being recalled
Companies: Bard Peripheral Vascular, Inc., 1625 West 3rd Street, Tempe, Arizona, United States, 85281.
How to identify it
Affected products: Bard Marquee 12g X 10 cm; Lot or serial number: 0001618258; Model or catalogue number: MQ1210
Affected products: Bard Marquee 12g X 10 cm; Lot or serial number: 0001633216; Model or catalogue number: MQ1210
The hazard
In September 2024, BD initiated a field action for specific lots of the Marquee™ Disposable Core Biopsy Instruments that were potentially manufactured missing the backend notch retention feature on the needle (figure 1), which results in inadequate securing of the needle inside the device. As part of the corrective actions associated with that issue, BD inspected all remaining needle sub-assembly lots that remained in stock at the manufacturing location. BD has since identified that one sub-assembly lot that underwent this inspection may not have been adequately sorted, thus there is a potential for specific lots of the Marquee™ Disposable Core Biopsy Instruments that were manufactured with that sub-assembly to contain needles that were not adequately inspected for the presence of the backend notch.
What to do
Contact the manufacturer if you require additional information.
The official notice
This page is a summary of the notice published by Health Canada, collected from Health Canada, CFIA and Transport Canada. Check the original before you act on it.
Read the official notice (opens in a new tab)