FDA Medical Device Recalls (openFDA)
CIVCO Medical Instruments Co., Inc.: CIVCO Needle Guide Bracket, REF numbers M001457100, P06013-10, and P03122-08, reusable non-sterile single-angle bracket for use with SonoSite L25 series tranducers, RX. The firm name on the label is CIVCO, Kalona, IA.
- Recall number
- Z-0562-2019
- Recalling firm
- CIVCO Medical Instruments Co., Inc.
- Product
- CIVCO Needle Guide Bracket, REF numbers M001457100, P06013-10, and P03122-08, reusable non-sterile single-angle bracket for use with SonoSite L25 series tranducers, RX. The firm name on the label is CIVCO, Kalona, IA.
- Status
- Terminated
- Initiated
- 2018-11-02
- Posted
- not on file
- Terminated
- 2020-11-20
- Reason
- The needle guide bracket may puncture the sterile cover applied over the transducer and bracket during assembly.
- Root cause
- Other
- Action
- The recalling firm began issuing letters dated 10/30/2918 via email on 11/2/2018 requesting return of the boxes of product or reusable brackets that may be in their inventory.
- Quantity
- 738 boxes
- Distribution
- Foreign distribution was made to Canada, Argentina, Australia, Austria, Belgium, Brazil, Chile, China, Colombia, Croatia, Cyprus, Denmark, Estonia, France, Germany, Hong Kong, India, Israel, Italy, Japan, Latvia, Lebanon, Lithuania, Netherlands, New Zealand, Philippines, Poland, Portugal, Qatar, Romania, Saudi Arabia, Singapore, South Africa, Spain, Switzerland, Taiwan, Trinidad/Tobago, Turkey, Ukraine, United Arab Emirates, and the United Kingdom.
- Lot, serial or model codes
- Boxes with lot numbers between A000012-A050663, M000880-M995980, and P022503, and all brackets in inventory that no longer have the product labeling.
- 510(k) numbers
- ["K030064"]
- PMA numbers
- not on file
- Product code
- ITX
- Firm FEI
- 3012763756
- Firm city
- Coralville
- 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