FDA Medical Device Recalls (openFDA)
Civco Medical Instruments Co. Inc.: CIVCO Needle Guide, REF 676-150, QTY 24, STERILE EO
- Recall number
- Z-2947-2018
- Recalling firm
- Civco Medical Instruments Co. Inc.
- Product
- CIVCO Needle Guide, REF 676-150, QTY 24, STERILE EO
- Status
- Terminated
- Initiated
- 2018-07-30
- Posted
- not on file
- Terminated
- 2020-09-16
- 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.
- 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 order@civco.com
- Quantity
- 3 units
- Distribution
- United States, Austria, Belgium, Denmark, France, Germany, Poland, Spain, Switzerland and United Kingdom
- Lot, serial or model codes
- UDI 00841436107334, Lot numbers: A035054, A042207
- 510(k) numbers
- ["K970514"]
- PMA numbers
- not on file
- Product code
- ITX
- Firm FEI
- 1937223
- Firm city
- Kalona
- Firm state
- IA
- Firm country
- not on file
Where this comes from
- Register
- FDA Medical Device Recalls (openFDA)
- Publisher
- U.S. Food and Drug Administration (openFDA)
- File
- device-recall-0001-of-0001.json.zip
- sha256
- b87518bfe2e8
- Size
- 288210821 bytes
- Published
- 2026-09-28
- Read
- 2026-09-29T08:25:23.626Z
- Source file
- Source file retained · verify
- Refresh due
- 2026-10-06
Unless otherwise noted, the content, data, documentation, code, and related materials on openFDA is public domain and made available with a Creative Commons CC0 1.0 Universal dedication.
Cite as
FDA Medical Device Recalls (openFDA) (U.S. Food and Drug Administration (openFDA)), device-recall-0001-of-0001.json.zip, sha256 b87518bfe2e8, published 2026-09-28