Recall Z-0576-2019— CIVCO Medical Instruments Co., Inc.

Name: FDA recall Z-0576-2019
Creator: U.S. Food and Drug Administration
Published: 2018-11-02

Class II · Terminated

Class II FDA medical device recall by CIVCO Medical Instruments Co., Inc., initiated 2018-11-02, terminated 2020-11-20. It names one FDA 510(k) clearance: K030064. Product: CIVCO Sales Demo Kit, REF DEMOGPGUIDE, for use by CIVCO and customer sales representatives..

Recalling firm: CIVCO Medical Instruments Co., Inc.
Classification: Class II
Status: Terminated
Initiated: 2018-11-02
Terminated: 2020-11-20
Firm location: Coralville, IA, United States

510(k) clearances named in this recall

1 on FDA's record

K030064 — ILOOK 25 NEEDLE GUIDE ATTACHMENT AND BRACKET ASSEMBLYSonosite,Inc.·cleared 2003-01-22

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

CIVCO Sales Demo Kit, REF DEMOGPGUIDE, for use by CIVCO and customer sales representatives.

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