FDA Device recall Z-1289-2021
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…
- FDA Device
- Class II
- terminated
- Published 2021-03-31
On 2021-03-31 the FDA classified a Class II recall of 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… by Bard Peripheral Vascular, citing 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.
Read the official FDA Device notice
| Agency | FDA Device |
|---|---|
| Recall number | Z-1289-2021 |
| Classification | Class II |
| Status | terminated |
| Initiated | 2021-01-14 |
| Published | 2021-03-31 |
| Last updated | 2026-09-13 11:56 UTC |
| Company | Bard Peripheral Vascular |
| Distribution | 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, PR, RI, SC, SD, TN, TX, UT, VA, VT, WA, WI, WV, WY |
Product
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
Reason
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.
Identifiers
| code_info | Catalog and Product Description MQ1210 BARD MARQUEE Disposable Core Biopsy Instrument, 12g x 10cm, MQ1213 BARD MA…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 B |
|---|
Status history
No status changes recorded since RecallRadar first saw this recall on 2026-09-13 11:56 UTC. Current status: terminated.
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All Bard Peripheral Vascular recalls
Source
Official record: https://api.fda.gov/device/enforcement.json?search=recall_number:%22Z-1289-2021%22
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