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Recall Observatory FDA recall evidence

Device product

BNX Fine Need Aspiration System (22GA); Material/Part#: DSN-22-01

Z-1476-2017

February 08, 2017

Class II

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-1476-2017

Official wording

Reason: Handle may break during use.

Code information: Lot number: B000000167

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

    reason.no_named_rule · v1.0.0

    Handle may break during use.