FDA recall Z-1260-2023

Bard Peripheral Vascular Inc · Class II · device

Product

Bard Mission Disposable Core Biopsy Instrument Kit: 16G x 10CM, REF: 1610MSK; 18G x 16CM, REF: 1816MSK

Reason for recall

The external diameter of the biopsy instrument is larger than the internal diameter of the coaxial needle, which could lead to: 1) Procedural delay, 2) Requirement of an additional device, 3), Needle tip breakage, if used despite incompatibility.

Distribution

Worldwide Distribution: US (Nationwide) includes states of: FL, MD, OH, CO, PA, TX, NC, CA, ME, MO, NV, MI, IL, NY, VA, AZ, NH, LA, WI, KY, MA, WA, CT, SD, OK, DC, IA, AR, GA, NE, NM, IN, NJ, MN, PR, AL, AK, SC, KS, OR, ID, VT, MT, WV, ND, TN, MS, HI, WY, RI and OUS countries of: Canada, Korea, Thailand and Taiwan. OUS: AR, AU, BE, CA, CN, CO, HK, IN, JP, KR, TH, TW

Key facts

Status
Ongoing
Initiation date
2023-02-28
Report date
2023-03-22
Voluntary/Mandated
Voluntary: Firm initiated
Location
Tempe, AZ, United States

Primary source

https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-1260-2023