FDAClass IIMarch 22, 2017

SharkCore LG Fine Needle Biopsy System recall

SharkCore LG Fine Needle Biopsy System (19GA); Material/Part#: DSL-19-01

Why was SharkCore LG Fine Needle Biopsy System recalled?

Handle may break during use.

What should I do if I have this product?

Review the official FDA enforcement record for current instructions.

What to do with a recalled product: refunds, receipts, safe disposal and how to report a problem.

Is my product affected?

Compare the item in your hand with every identifier below from the official FDA record. Only products that match the listed product and lot, UPC or model codes are part of this recall.

Which lot codes, UPCs or models are affected?

Lot number: B000000166

Product
SharkCore LG Fine Needle Biopsy System (19GA); Material/Part#: DSL-19-01
Recalling firm
Medtronic
Quantity
1,096 Units (total for all products)
Distribution
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
Recall date
March 22, 2017
Classification
Class II
Status
Terminated
Agency
FDA (device)
Open FDA enforcement record Latest recalls