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MARQUEE recallZ-1289-2021 · Bard Peripheral Vascular Inc · initiated Jan 14, 2021

Terminated

Is my device affected?

  1. Compare the model, catalog and lot or serial numbers on your device or its packaging with the code information below. A recall usually covers only specific models or lots.
  2. If yours is listed, follow the instructions from Bard Peripheral Vascular Inc or your healthcare provider. The company's action is summarized under what the company is doing.
  3. Do not stop using a prescribed or implanted device on your own — talk to your healthcare provider first.

Where to find your model and lot numbers · What recall classes and statuses mean

Why it was 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.

FDA root cause category: Process control

What the company is doing

On 02/11/2021, the firm sent an "UGENT MEDICAL DEVICE RECALL" Notification Letter via FedEx or email to customers/distributors informing them that the Recalling Firm has received reports that 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 and may results in (1) prolongation of the biopsy procedures as the user obtains a replacement device, (2) undershooting the lesion unsuspectedly, compromising the sample quality and potentially leading to a misdiagnosis (3) or if the penetration is overshot, the device may pierce adjacent tissue and/or organs causing injury. Customers are instructed to: 1. Check all inventory locations within their institution for the catalog/lot number combination listed in this recall notice and destroy all affected product remaining in their possession. 2. Share the recall notice with any users of the product, within their facilities, to ensure they are also aware of this recall. 3. If purchased this product from a distributor, contact the distributor for further instructions. 4. Complete and return the attached Customer Response Form to the Recalling Firm's contact noted on the form confirming acknowledgement of the recall notification, whether or not they have any affected product, so that Recalling Firm may acknowledge the receipt of the notification and process any applicable replacement orders. 5. Report any adverse health consequences experienced with the use of this product to the Recalling Firm. Actions to be taken by the Recalling Firm: 1. The firm will process replacement orders for all customers affected by the recall following receipt of the completed Customer Response Form. 2. Depending on the specific product code, there may be delays in the fulfillment of replacement orders. the firm understands that supply interruptions can impact our customers ability to provide the best care for their patients and takes t

Recall details

Recall number
Z-1289-2021
Status
Terminated
Initiated by the company
Jan 14, 2021
Recalling firm
Bard Peripheral Vascular Inc
Quantity
Total 131,876 kits (102,210 kits U.S. and 29,666 kits O.U.S.)
Product code
KNW
FDA submissions
K133948
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

Product description

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

Code information (models, lots, serial numbers)

Show the full code information (7k characters)

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

Devices named in this recall

24 devices in the FDA device registry whose identifier appears in the recall's code information.

Product lines

Sources and updates

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