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U.S. Department of Health and Human Services

Class 2 Device Recall Disposable Core Tissue Biopsy Needle

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 Class 2 Device Recall Disposable Core Tissue Biopsy Needlesee related information
Date Initiated by FirmAugust 02, 2024
Date PostedSeptember 20, 2024
Recall Status1 Open3, Classified
Recall NumberZ-3206-2024
Recall Event ID 95174
510(K)NumberK934370 
Product Classification Biopsy needle - Product Code FCG
ProductBARD MAGNUM Disposable Core Tissue Biopsy Needle REF: MN1410 MN 1420 MN1610 MN1616 MN1820 MN2010 The Magnum Biopsy System (instrument and needles) is intended for use in obtaining biopsies from soft tissues such as liver, kidney, prostate, breast, spleen, lymph nodes and various soft tissue tumors.
Code Information Product Name: Magnum 14g x 10cm Catalog Number: MN1410 Lot Numbers / UDI code: REJP3295 / (01)00801741084249(17)270131(10)REJP3295 REJP2228 / (01)00801741084249(17)270131(10)REJP2228 REJN2583 / (01)00801741084249(17)261231(10)REJN2583 REJQ2851 / (01)00801741084249(17)270228(10)REJQ2851 REJQ0831 / (01)00801741084249(17)270228(10)REJQ0831 Product Name: Magnum 14g x 20cm Catalog Number: MN1420 Lot Numbers / UDI code: REHX2867 / (01)00801741084270(17)260930(10)REHX2867 Product Name: Magnum 16g x 10cm Catalog Number: MN1610 Lot Numbers / UDI code: REJN0587 / (01)00801741084287(17)261231(10)REJN0587 Product Name: Magnum 16g x 16cm Catalog Number: MN1616 Lot Numbers / UDI code: REJP3289 / (01)00801741084300(17)270131(10)REJP3289 Product Name: Magnum 18g x 20cm Catalog Number: MN1820 Lot Numbers / UDI code: REJS1418 / (01)00801741084355(17)270430(10)REJS1418 Product Name: Magnum 20g x 10cm Catalog Number: MN2010 Lot Numbers / UDI code: REJQ1160 / (01)00801741084386(17)270228(10)REJQ1160
FEI Number 2020394
Recalling Firm/
Manufacturer		 Bard Peripheral Vascular Inc
1625 W 3rd St Bldg 1
850 W. Rio Salado Prkwy.
Tempe AZ 85281-2438
For Additional Information ContactLaura Corrado
267-810-4653
Manufacturer Reason
for Recall		Due to possible packaging damage (indentations/cuts) cause by manufacturing process. As a result of the packaging damage, may cause the sterile barrier to be compromised.
FDA Determined
Cause 2		Packaging change control
ActionOn 08/28/2024, the firm sent an "URGENT: Medical Device Product Removal" Letter via FedEx and/or email to customers informing them that BD has identified through internal inspections, that the packaging of the Magnum Biopsy Needle may have been damaged by indentations unintentionally made during manufacture, potentially compromising the sterile barrier that may be hard to detect by the end user. Customers are instructed to: 1.Discontinue use of product listed in the letter, and immediately dispose of all affected product remaining in their possession in accordance with their local facility s process. 2.Share this notification with all users within their facility network of the product to ensure they are also aware of this field action. If the affected products have been distributed further, ensure that these entities are contacted and informed of the recall. 3.Complete and return the attached Customer Response Form and return it to the BD contact noted on the form whether or not customers have any of the product so that BD may acknowledge their receipt of this notification and subsequently process any required product replacement. 4.Indicate on the response form the quantity of product identified at their facility and confirm that this product inventory was disposed of. 5.If customers purchased this product from a distributor, contact their distributor for further instructions and credit resolution. Contact BD representative if assistance is needed with this process or contact the number below for further assistance: North American Regional Complaint Center for Recall questions, Product Complaints, Technical Questions - Phone: 1-844-8BD-LIFE (1-844-823-5433) Say Recall when prompted Mon Fri 8:00am and 5:00pm CT or Email: productcomplaints@bd.com. Recall Related Questions - BDRC13@BD.COM
Quantity in Commerce60 (U.S.) and 5,160 (O.U.S.)
DistributionWorldwide - U.S. Nationwide distribution in the Puerto Rico and the countries of Canada, Pakistan, Peru, India, Malaysia, China, Brazil, Mexico, Japan, Chile, Australia.
Total Product Life CycleTPLC Device Report
1 A record in this database is created when a firm initiates a correction or removal action. The record is updated if the FDA identifies a violation and classifies the action as a recall, and it is updated for a final time when the recall is terminated. Learn more about medical device recalls.
2 Per FDA policy, recall cause determinations are subject to modification up to the point of termination of the recall.
3 The manufacturer has initiated the recall and not all products have been corrected or removed. This record will be updated as the status changes.
510(K) Database510(K)s with Product Code = FCG
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