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

FDA Device Recall #Z-3206-2024 — Class II — August 2, 2024

Recall Summary

Recall Number Z-3206-2024
Classification Class II — Moderate risk
Date Initiated August 2, 2024
Status Ongoing
Voluntary Voluntary: Firm initiated

Recalling Firm

Firm Bard Peripheral Vascular Inc
Location Tempe, AZ
Product Type Devices
Quantity 60 (U.S.) and 5,160 (O.U.S.)

Product Description

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.

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.

Distribution Pattern

Worldwide - U.S. Nationwide distribution in the Puerto Rico and the countries of Canada, Pakistan, Peru, India, Malaysia, China, Brazil, Mexico, Japan, Chile, Australia.

Lot / 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

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Z-1244-2025 Class I Rotarex Atherectomy System and Instructions for... Feb 5, 2025
Z-0467-2025 Class II Bard Marquee Disposable Core Biopsy Instrument ... Sep 30, 2024

Frequently Asked Questions

Sterility recalls for medical devices vary in severity. If you have already had a procedure using a potentially non-sterile device, contact your healthcare provider immediately — you may need monitoring for signs of infection. Symptoms to watch for include fever, redness or swelling at the surgical site, unusual pain, or discharge. For devices that have not yet been used, they should be quarantined and returned to the manufacturer per the recall notice. Non-sterile implants can cause serious infections; early detection and treatment are critical.

Class I recalls indicate a reasonable probability of serious adverse health consequences or death from the defect. Class II recalls involve products that may cause temporary or medically reversible adverse health consequences, or where serious consequences are remote. Class III recalls cover products not likely to cause any adverse health consequences, typically involving technical regulatory violations. The classification guides urgency — Class I recalls require immediate action, while Class III may simply involve returning a product or acknowledging a labeling change. Always read the specific recall notice for recommended patient actions.

Report problems with medical devices to the FDA through MedWatch at 1-800-FDA-1088 or online at FDA.gov/safety/medwatch. Healthcare facilities are required by law to report device-related serious injuries and deaths. Patients and consumers can also report voluntarily. Include the device name, manufacturer, model number, and a description of the problem and any patient outcome. Reports from patients and clinicians help the FDA identify emerging safety signals and may trigger investigations that lead to recalls of dangerous devices.

What Should You Do?

Stop using this device if you are affected by this recall. Contact your healthcare provider and the manufacturer immediately for guidance. Report adverse events to FDA MedWatch.

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