FDA recall Z-3206-2024

Bard Peripheral Vascular Inc · Class II · device

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 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

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

Key facts

Status
Ongoing
Initiation date
2024-08-02
Report date
2024-10-02
Voluntary/Mandated
Voluntary: Firm initiated
Location
Tempe, AZ, United States

Primary source

https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-3206-2024