Recall Z-3206-2024— Bard Peripheral Vascular Inc

Name: FDA recall Z-3206-2024
Creator: U.S. Food and Drug Administration
Published: 2024-08-02

Class II · Ongoing

Class II FDA medical device recall by Bard Peripheral Vascular Inc, initiated 2024-08-02. It names one FDA 510(k) clearance: K934370. 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.. Reason: 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..

Recalling firm: Bard Peripheral Vascular Inc
Classification: Class II
Status: Ongoing
Initiated: 2024-08-02
Firm location: Tempe, AZ, United States

510(k) clearances named in this recall

1 on FDA's record

K934370 — BIP BIOPSY NEEDLE MODIFICATIONBip USA, Inc.·cleared 1994-03-07

K-numbers as listed on FDA's Recall Enterprise System record for this event (openFDA device/recall k_numbers). The recall may also cover devices cleared under other submissions not named here.

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.

Data sourced from openFDA. This site is unofficial and independent of the FDA.