ClearanceBrief
Recall Z-2947-2018 ยท ITX Transducer, Ultrasonic, Diagnostic

Civco Medical Instruments Co. Inc.

CIVCO Needle Guide, REF 676-150, QTY 24, STERILE EO

DateJul 30, 2018
StatusTerminated
ReasonThe 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.
Root causeProcess control
ActionThe firm initiated communication on 07/30/2018 by email and telephone calls. The firm requested return of the recalled product. Questions may be made to the Account Representative by calling CIVCO Medical Solutions, Multi-Modality Imaging at 800-445-6741 or 319-248-6757 7:00 AM - 5:30 PM CST or by email at order@civco.com
Quantity3 units
DistributionUnited States, Austria, Belgium, Denmark, France, Germany, Poland, Spain, Switzerland and United Kingdom
FDA recordOpen on fda.gov

510(k) clearances named in this recall

K970514DISPOSABLE TRANSRECTAL/TRANSVAGINAL/ENDOCAVITY ULTRASOUND NEEDLE INSTRUMENT GUIDE
CIVCO Medical Instruments Co., Inc., Jun 20, 1997