BARD MARQUEE Disposable Core Biopsy Instruments XX.Xcm, XX.Xcm, XXg x XXcm REF XXXXXXX Note - for definition of the "X's refer to Tyvek Lid Label.pdf" uploaded in Associated Documents
Check against the official notice below — it lists the full affected range.
Bard Peripheral Vascular Inc. is recalling BARD MARQUEE Disposable Core Biopsy Instruments due to a defect in the Penetration Depth Switch, which detaches from the device during use. This switch is used to select the desired penetration depth of the biopsy needle when performing soft tissue biopsies. A total of 131,876 kits have been distributed, including 102,210 kits in the United States across all states and the District of Columbia, as well as Puerto Rico, and 29,666 kits in Australia, Belgium, Canada, Europe, India, and Singapore.
The recalled devices include multiple catalog numbers in the BARD MARQUEE line, ranging from 12-gauge to 18-gauge needles with various lengths from 10 to 25 centimeters, available as individual instruments or kits. The record does not specify a remedy for consumers who possess these devices.
Written by software from the official notice below. Not reviewed by a lawyer.
Due to the Penetration Depth Switch used to select the desired penetration depth of the biopsy needle for soft tissue biopsies, detaches from the device during use.
Reason for recall: Due to the Penetration Depth Switch used to select the desired penetration depth of the biopsy needle for soft tissue biopsies, detaches from the device during use. Distribution: U.S.: AK, AL, AR, AZ, CA, CO, CT, DC, DE, FL, GA, HI, IA, ID, IL, IN, KS, KY, LA, MA, MD, ME, MI, MN, MO, MS, MT, NC, ND, NE, NH, NJ, NM, NV, NY, OH, OK, OR, PA, Puerto Rico, RI, SC, SD, TN, TX, UT, VA, VT, WA, WI, WV, and WY O.U.S.: Australia, Belgium, Canada, Europe, India, and Singapore Quantity: Total 131,876 kits (102,210 kits U.S. and 29,666 kits O.U.S.) Lot/code info: Catalog and Product Description MQ1210 BARD MARQUEE Disposable Core Biopsy Instrument, 12g x 10cm, MQ1213 BARD MARQUEE Disposable Core Biopsy Instrument, 12g x 13cm, MQ1410 BARD MARQUEE Disposable Core Biopsy Instrument, 14g x 10cm, MQ1413 BARD MARQUEE Disposable Core Biopsy Instrument, 14g x 13cm, MQ1416 BARD MARQUEE Disposable Core Biopsy Instrument, 14g x 16cm, MQ1610 BARD MARQUEE Disposable Core Biopsy Instrument, 16g x 10cm, MQ1616 BARD MARQUEE Disposable Core Biopsy Instrument, 16g x 16cm, MQ1620 BARD MARQUEE Disposable Core Biopsy Instrument, 16g x 20cm, MQ1810 BARD MARQUEE Disposable Core Biopsy Instrument, 18g x 10cm, MQ1816 BARD MARQUEE Disposable Core Biopsy Instrument, 18g x 16cm, MQ1820 BARD MARQUEE Disposable Core Biopsy Instrument, 18g x 20cm, MQ1825 BARD MARQUEE Disposable Core Biopsy Instrument, 18g x 25cm, MQK1210 BARD MARQUEE Disposable Core Biopsy Instrument Kit, 12g x 10cm, MQK1213 BARD MARQUEE Disposable Core Biopsy Instrument Kit, 12g x 13cm, MQK1410 BARD MARQUEE Disposable Core Biopsy Instrument Kit, 14g x 10cm, MQK1413 BARD MARQUEE Disposable Core Biopsy Instrument Kit, 14g x 13cm, MQK1416 BARD MARQUEE Disposable Core Biopsy Instrument Kit, 14g x 16cm, MQK1610 BARD MARQUEE Disposable Core Biopsy Instrument Kit, 16g x 10cm, MQK1810 BARD MARQUEE Disposable Core Biopsy Instrument Kit, 18g x 10cm, MQK1816 BARD MARQUEE Disposable Core Biopsy Instrument Kit, 18g x 16cm, MQK1820 BARD MARQUEE Disposable Core Biopsy Instrument Kit, 18g x 20cm, MQK1825 BARD MAR
Official record: FDA (Device enforcement) ↗
Republished from the official source above; details can change — the source record controls.