SharkCore LG Fine Needle Biopsy System (19GA); Material/Part#: DSL-19-01
This recall has been terminated (originally issued February 28, 2017).
- Company
- Medtronic
- Recall Initiated
- February 8, 2017
- Posted
- February 28, 2017
- Terminated
- July 18, 2019
- Recall Number
- Z-1475-2017
- Quantity
- 1,096 Units (total for all products)
- Firm Location
- North Haven, CT
- Official Source
- View on FDA website ↗
Reason for Recall
Handle may break during use.
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
Lot / Code Info
Lot number: B000000166
Root Cause
Nonconforming Material/Component
Action Taken
A recall was initiated on February 8, 2017. Customers were notified via Federal Express and the letter instructs customers to discontinue use of the product and return all inventory to Medtronic (Covidien), 1856 Corporate Dr. Suite 140 Norcross, GA 30093, Attention: Field Returns Department. Disposition of product within Medtronic control and customer returned devices: Will be reworked.