Recall Z-2888-2018— Civco Medical Instruments Co. Inc.

Name: FDA recall Z-2888-2018
Creator: U.S. Food and Drug Administration
Published: 2018-02-23

Class II · Terminated

Class II FDA medical device recall by Civco Medical Instruments Co. Inc., initiated 2018-02-23, terminated 2020-10-06. It names one FDA 510(k) clearance: K093713. Product: CIVCO lnfiniti Needle Guide Bracket. used for performing needle-guided (or catheter) procedures with the use of diagnostic ultrasound transducers. Product Usage: The bracket and disposable guide provide physicians with a tool for performing needle-guided (or catheter) procedures with the use of diagnostic ultrasound transducers.. Reason: A cover failed leak testing during validation testing of new needle guides from a replacement tool..

Recalling firm: Civco Medical Instruments Co. Inc.
Classification: Class II
Status: Terminated
Initiated: 2018-02-23
Terminated: 2020-10-06
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 lnfiniti Needle Guide Bracket. used for performing needle-guided (or catheter) procedures with the use of diagnostic ultrasound transducers. Product Usage: The bracket and disposable guide provide physicians with a tool for performing needle-guided (or catheter) procedures with the use of diagnostic ultrasound transducers.

Reason for recall

A cover failed leak testing during validation testing of new needle guides from a replacement tool.

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