Z-2946-2018Class II

CIVCO Needle Guide, REF 676-144, QTY 24, STERILE EO

Name: Z-2946-2018 CIVCO Needle Guide, REF 676-144, QTY 24, STERILE EO
Creator: Civco Medical Instruments Co. Inc.
Published: 2018-07-30
License: https://open.fda.gov/license/

CIVCO Medical Instruments Co., Inc. / initiated 2018-07-30 / Terminated / root cause: manufacturing process

FDA source

Civco Medical Instruments Co. Inc. began a recall of CIVCO Needle Guide, REF 676-144, QTY 24, STERILE EO on 2018-07-30. FDA classified it as Class II and gives the reason as "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". As of 2026-09-10, the recall status on record is Terminated, and MDM tags the root cause as manufacturing process.

Recall record

Recall number: Z-2946-2018
Classification: Class II
Status: Terminated
Initiated: 2018-07-30
Posted: 2018-08-29
Terminated: 2020-09-16
Recalling firm: CIVCO Medical Instruments Co., Inc.
Product: CIVCO Needle Guide, REF 676-144, QTY 24, STERILE EO
Product code: ITX Transducer, Ultrasonic, Diagnostic
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.
Root cause tag: manufacturing process
FDA root cause: Process control
Action: The 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 [email protected]
Quantity in commerce: 107 units
Distribution: United States, Austria, Belgium, Denmark, France, Germany, Poland, Spain, Switzerland and United Kingdom
Product codes and lots: UDI 00841436107327, Lot numbers: A018067, A018067, A021026, A021026, A021226, A021226, A021226, A022447, A022447, A023876, A023876, A025137, A025137, A025137, A025137, A02560, A025606, A025606, A025606, A026609, A026609, A026609, A026609, A026610, A026610, A026610, A028159, A028159, A028645, A029293, A029293, A029293, A029383, A032036, A032036, A032036, A032036, A032036, A032036, A033139, A033139, A033139, A033139, A033153, A033153, A035009, A035009, A035009, A035010, A035010, A035010, A035010, A035010, A035568, A035568, A037150, A037231, A037231, A037231, A037585, A037585, A039417, A039417, A040376, A040376, A040839, A041444, A041444, A041444, A041723, A041723

Enforcement reports

One row per recalled product line

FDA enforcement reports joined to recall event Z-2946-2018
Recall number	Class	Status	Voluntary or mandated	Report date	Classified
Z-2946-2018	Class II	Terminated	Voluntary: Firm initiated	2018-09-05	2018-08-29
Z-2947-2018	Class II	Terminated	Voluntary: Firm initiated	2018-09-05	2018-08-29

Product code ITX

K970514Class IIDisposable Transrectal/transvaginal/endocavity Ultrasound Needle Instrument GuideCIVCO Medical Instruments Co., Inc. / cleared 1997-06-20

MDM coverage of this record lists here, newest first.

About this record

Sourced from the FDA device recall database and the FDA enforcement reports, both ingested from openFDA. The recall record supplies the product, the reason and the product code; the enforcement report supplies the classification. The two datasets are exported by FDA on different days, and the date above is the older of the two, so nothing on this page is newer than it says.

MDM adds the root cause tag, derived from FDA’s own root cause text, and the cross-links to the product code, the clearances named on the record and MDM coverage. Where a recall has not been joined to an enforcement report, no classification is shown.

Data as of 2026-10-07, the FDA export date for this dataset. Page last changed 2026-09-05. View this recall on fda.gov (opens on fda.gov)