Device product
SharkCore LG Fine Needle Biopsy System (19GA); Material/Part#: DSL-19-01
Z-1475-2017
Product summary
- Firm
- Medtronic
- Event
- Event 76497
- Status
- Terminated
- Classification
- Class II
- Quantity
- 1,096 Units (total for all products)
- Official record key
device-enforcement:Z-1475-2017
Official wording
Reason: Handle may break during use.
Code information: Lot number: B000000166
Distribution pattern: 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
Derived failure modes
-
Unknown
Handle may break during use.