Needle Guide recallZ-2946-2018 · Civco Medical Instruments Co. Inc. · initiated Jul 30, 2018
Terminated
Is my device affected?
- Compare the model, catalog and lot or serial numbers on your device or its packaging with the code information below. A recall usually covers only specific models or lots.
- If yours is listed, follow the instructions from Civco Medical Instruments Co. Inc. or your healthcare provider. The company's action is summarized under what the company is doing.
- Do not stop using a prescribed or implanted device on your own — talk to your healthcare provider first.
Where to find your model and lot numbers · What recall classes and statuses mean
Why it was recalled
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.
FDA root cause category: Process control
What the company is doing
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]
Recall details
- Recall number
- Z-2946-2018
- Status
- Terminated
- Initiated by the company
- Jul 30, 2018
- Recalling firm
- Civco Medical Instruments Co. Inc.
- Quantity
- 107 units
- Product code
- ITX
- FDA submissions
- K970514
- Distribution
- United States, Austria, Belgium, Denmark, France, Germany, Poland, Spain, Switzerland and United Kingdom
Product description
CIVCO Needle Guide, REF 676-144, QTY 24, STERILE EO
Code information (models, lots, serial numbers)
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
Devices named in this recall
1 device in the FDA device registry whose identifier appears in the recall's code information.
- Needle Guide 676-144, 10563771Civco Medical Instruments CO., Inc. · Transducer, ultrasonic, diagnostic1 recall0 reports
Product lines
Other devices under the same FDA submission
1 device cleared under K970514 are not named by identifier in this recall. One submission often covers many models, so they may or may not be affected.
- Needle Guide 676-150Civco Medical Instruments CO., Inc. · Transducer, ultrasonic, diagnostic1 recall0 reports
Other products in the same recall event
The FDA groups related products into one recall event (event 80656).
- Z-2947-2018 · TerminatedCIVCO Needle Guide, REF 676-150, QTY 24, STERILE EO
Sources and updates
- Recall record: FDA Medical Device Recalls, file dated Oct 16, 2026 · View the FDA recall notice ↗
- Devices: FDA GUDID, file dated Oct 13, 2026. Devices are linked when their identifier (with a valid check digit) appears in the recall's code information.
- Page last rebuilt: Oct 16, 2026. Text above is shown as published by the FDA.
How recalls are matched to devices · Editorial policy · Report an error on this page