FDA-Device2017-03-22Class II

SharkCore Fine Needle Biopsy System (25GA); Material/Part#: DSC-25-01

Medtronic
Hazard

Handle may break during use.

Sold states
US Distribution to AL, AR, AZ, CA, CO, CT, DC, DE, FL, GA, HI, IA, IL, IN, KS, LA, MA, MD, MI, MN, MO, NC, ND, NH, NJ, NM, NV, NY, OH, OK, OR, PA, RI, SC, SD, TN, TX, VA, WA, WI; and countries of DK and DE
Affected count
1,096 Units (total for all products)
Manufactured in
60 Middletown Ave, N/A, North Haven, CT, United States
Products
SharkCore Fine Needle Biopsy System (25GA); Material/Part#: DSC-25-01

Official notice

https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-1474-2017

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