FDAClass IIMarch 31, 2021

BARD MARQUEE Disposable Core Biopsy Instruments XX.Xcm recall

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"…

Why was BARD MARQUEE Disposable Core Biopsy Instruments XX.Xcm recalled?

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.

What should I do if I have this product?

Review the official FDA enforcement record for current instructions.

What to do with a recalled product: refunds, receipts, safe disposal and how to report a problem.

Is my product affected?

Compare the item in your hand with every identifier below from the official FDA record. Only products that match the listed product and lot, UPC or model codes are part of this recall.

Which lot codes, UPCs or models are affected?

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 MARQUEE Disposable Core Biopsy Instrument Kit, 18g x 25cm, MQK2010 BARD MARQUEE Disposable Core Biopsy Instrument Kit, 20g x 10cm, MQK2016 BARD MARQUEE Disposable Core Biopsy Instrument Kit, 20g x 16cm UDI Codes: (01)801741097119(17)230328(10)0001353340, (01)801741097119(17)230328(10)0001353342, (01)801741097119(17)230328(10)0001353401, (01)801741097119(17)230328(10)0001356645, (01)801741097119(17)230328(10)0001358065, (01)801741097119(17)230428(10)0001359983, (01)801741097119(17)230628(10)0001369253, (01)801741097126(17)230328(10)0001353402, (01)801741097126(17)230428(10)0001359984, (01)801741097126(17)230628(10)0001369256, (01)801741097133(17)230328(10)0001353403, (01)801741097133(17)230328(10)0001353404, (01)801741097133(17)230328(10)0001356410, (01)801741097133(17)230328(10)0001356409, (01)801741097133(17)230328(10)0001356886, (01)801741097133(17)230328(10)0001356888, (01)801741097133(17)230428(10)0001359150, (01)801741097133(17)230428(10)0001359152, (01)801741097133(17)230428(10)0001359149, (01)801741097133(17)230428(10)0001359151, (01)801741097133(17)230428(10)0001359988, (01)801741097133(17)230528(10)0001363603, (01)801741097133(17)230528(10)0001363604, (01)801741097133(17)230528(10)0001364078, (01)801741097133(17)230528(10)0001364076, (01)801741097133(17)230528(10)0001364077, (01)801741097133(17)230528(10)0001368474, (01)801741097133(17)230628(10)0001369045, (01)801741097133(17)230628(10)0001369046, (01)801741097140(17)230328(10)0001357081, (01)801741097140(17)230628(10)0001369273, (01)801741097157(17)230328(10)0001357079, (01)801741097164(17)230328(10)0001353246, (01)801741097164(17)230328(10)0001356414, (01)801741097164(17)230428(10)0001359989, (01)801741097164(17)230528(10)0001364079, (01)801741097164(17)230628(10)0001369264, (01)801741097171(17)230328(10)0001356999, (01)801741097171(17)230428(10)0001359990, (01)801741097188(17)230328(10)0001353723, (01)801741097195(17)230328(10)0001353492, (01)801741097195(17)230428(10)0001359991, (01)801741097195(17)230528(10)0001364091, (01)801741097195(17)230628(10)0001369267, (01)801741097201(17)230328(10)0001353722, (01)801741097218(17)230528(10)0001364092, (01)801741097218(17)230528(10)0001364093, (01)801741097218(17)230628(10)0001369270, (01)801741097225(17)230328(10)0001353721, (01)801741097225(17)230328(10)0001355807, (01)801741097225(17)230428(10)0001359994, (01)801741097225(17)230528(10)0001364090, (01)801741097263(17)230328(10)0001353400, (01)801741097263(17)230328(10)0001353399, (01)801741097263(17)230328(10)0001356646, (01)801741097263(17)230428(10)0001359178, (01)801741097263(17)230528(10)0001364069, (01)801741097263(17)230528(10)0001364070, (01)801741097263(17)230528(10)0001366667, (01)801741097263(17)230628(10)0001369252, (01)801741097263(17)230628(10)0001371860, (01)801741097270(17)230528(10)0001364072, (01)801741097270(17)230628(10)0001369259, (01)801741097287(17)230328(10)0001353727, (01)801741097287(17)230328(10)0001356411, (01)801741097287(17)230328(10)0001356412, (01)801741097287(17)230428(10)0001358408, (01)801741097287(17)230428(10)0001358409, (01)801741097287(17)230428(10)0001358414, (01)801741097287(17)230428(10)0001359999, (01)801741097287(17)230428(10)0001358413, (01)801741097287(17)230528(10)0001364084, (01)801741097287(17)230528(10)0001364085, (01)801741097287(17)230528(10)0001364082, (01)801741097287(17)230528(10)0001364080, (01)801741097287(17)230528(10)0001364081, (01)801741097287(17)230528(10)0001367194, (01)801741097287(17)230528(10)0001367195, (01)801741097287(17)230528(10)0001367196, (01)801741097287(17)230528(10)0001368556, (01)801741097287(17)230528(10)0001368555, (01)801741097287(17)230528(10)0001368760, (01)801741097287(17)230628(10)0001369292, (01)801741097294(17)230428(10)0001360001, (01)801741097300(17)230228(10)0001347094, (01)801741097300(17)230328(10)0001357065, (01)801741097317(17)230328(10)0001357859, (01)801741097317(17)230528(10)0001364088, (01)801741097317(17)230628(10)0001369278, (01)801741097348(17)230328(10)0001353725, (01)801741097348(17)230428(10)0001360028, (01)801741097348(17)230628(10)0001369289, (01)801741097355(17)230528(10)0001364089, (01)801741097355(17)230628(10)0001369284, (01)801741097362(17)230628(10)0001369290, (01)801741097379(17)230328(10)0001353724, (01)801741097379(17)230428(10)0001360029, (01)801741097386(17)230628(10)0001369272, (01)801741097393(17)230428(10)0001360030, (01)801741097393(17)230628(10)0001369276, Lot Numbers: 0001353340, 0001353342, 0001353401, 0001356645, 0001358065, 0001359983, 0001369253, 0001353402, 0001359984, 0001369256, 0001353403, 0001353404, 0001356410, 0001356409, 0001356886, 0001356888, 0001359150, 0001359152, 0001359149, 0001359151, 0001359988, 0001363603, 0001363604, 0001364078, 0001364076, 0001364077, 0001368474, 0001369045, 0001369046, 0001357081, 0001369273, 0001357079, 0001353246, 0001356414, 0001359989, 0001364079, 0001369264, 0001356999, 0001359990, 0001353723, 0001353492, 0001359991, 0001364091, 0001369267, 0001353722, 0001364092, 0001364093, 0001369270, 0001353721, 0001355807, 0001359994, 0001364090, 0001353400, 0001353399, 0001356646, 0001359178, 0001364069, 0001364070, 0001366667, 0001369252, 0001371860, 0001364072, 0001369259, 0001353727, 0001356411, 0001356412, 0001358408, 0001358409, 0001358414, 0001359999, 0001358413, 0001364084, 0001364085, 0001364082, 0001364080, 0001364081, 0001367194, 0001367195, 0001367196, 0001368556, 0001368555, 0001368760, 0001369292, 0001360001, 0001347094, 0001357065, 0001357859, 0001364088, 0001369278, 0001353725, 0001360028, 0001369289, 0001364089, 0001369284, 0001369290, 0001353724, 0001360029, 0001369272, 0001360030, 0001369276

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"…
Recalling firm
Bard Peripheral Vascular Inc
Quantity
Total 131,876 kits (102,210 kits U.S. and 29,666 kits O.U.S.)
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
Recall date
March 31, 2021
Classification
Class II
Status
Terminated
Agency
FDA (device)
Open FDA enforcement record Latest recalls