FDAFDA · Food and drugs·Recall number Z-1564-2023
Bard Mission Disposable Core Biopsy Instrument Kit: REF: 2010MSK, 20G x 10CM; REF: 2016MSK, 20G x 16CM
Published May 17, 2023 · Recall initiated: April 11, 2023
Status when published: Ongoing — openFDA updates weekly, so this field may not reflect the current status. Always confirm with the official notice.
What's the hazard
Coaxial cannula internal diameter and length of biopsy instruments exceed the external diameter and length of the biopsy needle, prohibiting the biopsy needle from properly fitting into the coaxial cannula and accessing the target tissue, which could lead to procedure delay, and insufficient sample acquisition requiring a repeat procedure.
What to do
Voluntary: Firm initiated · Letter
Recall details
- Manufacturer
- Bard Peripheral Vascular Inc
- Distributor
- US Nationwide Distribution: PR, AK, AL, AR, AZ, CA, CO, CT, DC, DE, FL, GA, HI, IA, ID, IL, IN, KS, KY, LA, MA, MD, ME, MI, MN, MO, MS, MT, NC, ND, NE, NH, NJ, NM, NV, NY, OH, OK, OR, PA, RI, SC, SD, TN, TX, UT, VA, VT, WA, WI, WV, WY . OUS: BE, CA, AU
- Lot
- REF/UDI-DI/Lot (Expiration Date): 2010MSK/00801741097089/0001445946(11/28/2024), 2016MSK/00801741097096/1458844(02/28/2025)
- Risk classification
- Class II
- Area (FDA)
- device
- Country
- United States
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