Z-3206-2024Class II

BARD MAGNUM Disposable Core Tissue Biopsy Needle REF: MN1410 MN 1420 MN1610 MN1616 MN1820 MN2010 The Magnum...

Name: Z-3206-2024 BARD MAGNUM Disposable Core Tissue Biopsy Needle REF: MN1410 MN 1420 MN1610 MN1616 MN1820 MN2010 The Magnum...
Creator: Bard Peripheral Vascular Inc
Published: 2024-08-02
License: https://open.fda.gov/license/

Bard Peripheral Vascular Inc / initiated 2024-08-02 / Open, Classified / root cause: packaging

FDA source

Bard Peripheral Vascular Inc began a recall of BARD MAGNUM Disposable Core Tissue Biopsy Needle REF: MN1410 MN 1420 MN1610 MN1616 MN1820 MN2010 The Magnum Biopsy System (instrument and needles) is intended... on 2024-08-02. FDA classified it as Class II and gives the reason as "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". As of 2026-09-10, the recall status on record is Open, Classified, and MDM tags the root cause as packaging.

Recall record

Recall number: Z-3206-2024
Classification: Class II
Status: Open, Classified
Initiated: 2024-08-02
Posted: 2024-09-20
Recalling firm: Bard Peripheral Vascular Inc
Product: BARD 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.
Product code: FCG Biopsy Needle
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.
Root cause tag: packaging
FDA root cause: Packaging change control
Action: On 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: [email protected]. Recall Related Questions - [email protected]
Quantity in commerce: 60 (U.S.) and 5,160 (O.U.S.)
Distribution: Worldwide - U.S. Nationwide distribution in the Puerto Rico and the countries of Canada, Pakistan, Peru, India, Malaysia, China, Brazil, Mexico, Japan, Chile, Australia.
Product codes and lots: 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

Enforcement reports

One row per recalled product line

FDA enforcement reports joined to recall event Z-3206-2024
Recall number	Class	Status	Voluntary or mandated	Report date	Classified
Z-3206-2024	Class II	Ongoing	Voluntary: Firm initiated	2024-10-02	2024-09-20

Product code FCG

K934370Class IIBip Biopsy Needle ModificationBip USA, Inc. / cleared 1994-03-07

MDM coverage of this record lists here, newest first.

About this record

Sourced from the FDA device recall database and the FDA enforcement reports, both ingested from openFDA. The recall record supplies the product, the reason and the product code; the enforcement report supplies the classification. The two datasets are exported by FDA on different days, and the date above is the older of the two, so nothing on this page is newer than it says.

MDM adds the root cause tag, derived from FDA’s own root cause text, and the cross-links to the product code, the clearances named on the record and MDM coverage. Where a recall has not been joined to an enforcement report, no classification is shown.

Data as of 2026-09-30, the FDA export date for this dataset. Page last changed 2026-09-05. View this recall on fda.gov (opens on fda.gov)