FDA Medical Device Recalls (openFDA)
Civco Medical Instruments Co. Inc.: eTRAX Needle System Starter Kit 12G (for Aurora Trackers), Part Number 667-149
- Recall number
- Z-1731-2026
- Recalling firm
- Civco Medical Instruments Co. Inc.
- Product
- eTRAX Needle System Starter Kit 12G (for Aurora Trackers), Part Number 667-149
- Status
- Open, Classified
- Initiated
- 2026-03-02
- Posted
- 2026-04-01
- Terminated
- not on file
- Reason
- There was an error in inspection and programming of the eTRAX needle sensor for Aurora trackers. The result is a potential for the needle tip position to be incorrectly identified on the user interface.
- Root cause
- Software change control
- Action
- An URGENT: MEDICAL DEVICE RECALL notification letter dated 3/2/26 was sent to customers. Actions to be taken by the Customer/User: CIVCO requests that you check your inventory for any eTRAX Needle Sensor for Aurora Trackers and complete the supplied response letter for the appropriate action. Please contact your distribution partner to return any existing inventory, or report its destruction by completing the attached response form. Please complete the enclosed response form even if you do not have any eTRAX Needle Sensor for Aurora Trackers remaining in your inventory to assist in our reconciliation process. Response forms can also be sent via email to distorder@civco.com. For questions, contact CIVCO at # 800-445-6741, or 319-248-6757. Type of Action by the Company: This notice is being communicated to all customers who have purchased an eTRAX Needle Sensor for Aurora Trackers from affected lots. CIVCO requests you provide this notification to the appropriate personnel within your facility. If the affected product was distributed outside of your organization, please notify those locations down to the medical facility level.
- Quantity
- 2 units
- Distribution
- US States: OH, PA, WA. China.
- Lot, serial or model codes
- UDI-DI: 00841436111034; Lot Number: A228672
- 510(k) numbers
- ["K092619"]
- PMA numbers
- not on file
- Product code
- IYO
- 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