Recall Z-1475-2017— Medtronic

Name: FDA recall Z-1475-2017
Creator: U.S. Food and Drug Administration
Published: 2017-02-08

Class II · Terminated

Class II FDA medical device recall by Medtronic, initiated 2017-02-08, terminated 2019-07-18. It names one FDA 510(k) clearance: K103668. Product: SharkCore LG Fine Needle Biopsy System (19GA); Material/Part#: DSL-19-01. Reason: Handle may break during use..

Recalling firm: Medtronic
Classification: Class II
Status: Terminated
Initiated: 2017-02-08
Terminated: 2019-07-18
Firm location: North Haven, CT, United States

510(k) clearances named in this recall

1 on FDA's record

K103668 — BNX FINE NEEDLE ASPIRATION SYSTEMBoston Endoscopic Engineering·cleared 2010-12-30

K-numbers as listed on FDA's Recall Enterprise System record for this event (openFDA device/recall k_numbers). The recall may also cover devices cleared under other submissions not named here.

Product description

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

Reason for recall

Handle may break during use.

Data sourced from openFDA. This site is unofficial and independent of the FDA.