Recall Z-0569-2019— CIVCO Medical Instruments Co., Inc.

Name: FDA recall Z-0569-2019
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 Needle Guide Starter Kit, REF numbers P12922-01 and P12922-02, Reusable non-sterile bracket with sterile (1cm, 1.5cm, 2cm depths) needle guides (5), (10.2 x 147cm) CIV-Flex covers (5) for use with SonoSite L25 series transducers, 21 GAUGE, Rx..

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 Needle Guide Starter Kit, REF numbers P12922-01 and P12922-02, Reusable non-sterile bracket with sterile (1cm, 1.5cm, 2cm depths) needle guides (5), (10.2 x 147cm) CIV-Flex covers (5) for use with SonoSite L25 series transducers, 21 GAUGE, Rx.

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