Recall Z-1475-2017 ยท FCG Biopsy Needle
Medtronic
SharkCore LG Fine Needle Biopsy System (19GA); Material/Part#: DSL-19-01
| Date | Feb 28, 2017 (initiated Feb 8, 2017) |
| Status | Terminated |
| Reason | Handle may break during use. |
| Root cause | Nonconforming Material/Component |
| Action | 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. |
| 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 |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
| K103668 | BNX FINE NEEDLE ASPIRATION SYSTEM Boston Endoscopic Engineering, Dec 30, 2010 |