Recall Z-2946-2018— Civco Medical Instruments Co. Inc.

Name: FDA recall Z-2946-2018
Creator: U.S. Food and Drug Administration
Published: 2018-07-30

Class II · Terminated

Class II FDA medical device recall by Civco Medical Instruments Co. Inc., initiated 2018-07-30, terminated 2020-09-16. It names one FDA 510(k) clearance: K970514. Product: CIVCO Needle Guide, REF 676-144, QTY 24, STERILE EO. Reason: The assembly of the needle guides were found to be either missing adhesive or did not have adequate adhesive to hold the assembled cannula in place on the needle guide..

Recalling firm: Civco Medical Instruments Co. Inc.
Classification: Class II
Status: Terminated
Initiated: 2018-07-30
Terminated: 2020-09-16
Firm location: Kalona, IA, United States

510(k) clearances named in this recall

1 on FDA's record

K970514 — DISPOSABLE TRANSRECTAL/TRANSVAGINAL/ENDOCAVITY ULTRASOUND NEEDLE INSTRUMENT GUIDECIVCO Medical Instruments Co., Inc.·cleared 1997-06-20

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, REF 676-144, QTY 24, STERILE EO

Reason for recall

The assembly of the needle guides were found to be either missing adhesive or did not have adequate adhesive to hold the assembled cannula in place on the needle guide.

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