Recall Z-0572-2019— CIVCO Medical Instruments Co., Inc.
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 674-038, Reusable non-sterile bracket with sterile needle guide (1cm, 1.5cm, 2cm depths) with (10.2 x 147cm) CIV-Flex cover for use with SonoSite L25 series transducers, 21 GAUGE, Rx. The firm name on the label is CIVCO, Kalona, IA...
- 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 recordK-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 674-038, Reusable non-sterile bracket with sterile needle guide (1cm, 1.5cm, 2cm depths) with (10.2 x 147cm) CIV-Flex cover for use with SonoSite L25 series transducers, 21 GAUGE, Rx. The firm name on the label is CIVCO, Kalona, IA..
Data sourced from openFDA. This site is unofficial and independent of the FDA.