Recall Z-0289-2016— Civco Medical Instruments Co. Inc.

Name: FDA recall Z-0289-2016
Creator: U.S. Food and Drug Administration
Published: 2015-10-21

Class II · Terminated

Class II FDA medical device recall by Civco Medical Instruments Co. Inc., initiated 2015-10-21, terminated 2017-02-28. It names one FDA 510(k) clearance: K093713. Product: CIVCO Tracking Bracket Starter Kit, Reusable non-sterile PercuNav tracking bracket with Infiniti Plus (12, 14, 16, 18GA) needle guides, Rx ONLY. REF 667-132. Large Gauge Infiniti Plus Needle Guides, used in needle-guided (or catheter) procedures with diagnostic ultrasound transducers.. Reason: Sterility of the product cannot be assured..

Recalling firm: Civco Medical Instruments Co. Inc.
Classification: Class II
Status: Terminated
Initiated: 2015-10-21
Terminated: 2017-02-28
Firm location: Kalona, IA, United States

510(k) clearances named in this recall

1 on FDA's record

K093713 — ULTRASOUND GENERAL PURPOSE GUIDANCE SYSTEMCivco Medical Instruments·cleared 2010-01-19

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 Tracking Bracket Starter Kit, Reusable non-sterile PercuNav tracking bracket with Infiniti Plus (12, 14, 16, 18GA) needle guides, Rx ONLY. REF 667-132. Large Gauge Infiniti Plus Needle Guides, used in needle-guided (or catheter) procedures with diagnostic ultrasound transducers.

Reason for recall

Sterility of the product cannot be assured.

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