FDA Device recall Z-0289-2016
CIVCO Tracking Bracket Starter Kit, Reusable non-sterile PercuNav tracking bracket with Infiniti Plus (12, 14, 16, 18GA) needle guides, Rx…
- FDA Device
- Class II
- terminated
- Published 2015-11-25
On 2015-11-25 the FDA classified a Class II recall of CIVCO Tracking Bracket Starter Kit, Reusable non-sterile PercuNav tracking bracket with Infiniti Plus (12, 14, 16, 18GA) needle guides, Rx… by Civco Medical Instruments, citing sterility of the product cannot be assured.
Read the official FDA Device notice
| Agency | FDA Device |
|---|---|
| Recall number | Z-0289-2016 |
| Classification | Class II |
| Status | terminated |
| Initiated | 2015-10-21 |
| Published | 2015-11-25 |
| Last updated | 2026-09-13 11:53 UTC |
| Company | Civco Medical Instruments |
| Distribution | US |
Product
CIVCO Tracking Bracket Starter Kit, Reusable non-sterile PercuNav tracking bracket with Infiniti Plus (12, 14, 16, 18GA) needle guides, Rx ONLY. REF 667-132. Large Gauge Infiniti Plus Needle Guides, used in needle-guided (or catheter) procedures with diagnostic ultrasound transducers.
Reason
Sterility of the product cannot be assured.
Identifiers
| code_info | M093630, M093640, M093650, M128890, M128930, M163120, M191470, M191880, M202970, M205490, M211000, M218540, M218550, M2…M093630, M093640, M093650, M128890, M128930, M163120, M191470, M191880, M202970, M205490, M211000, M218540, M218550, M218560, M240080, M250210, M262470, M308100, M328800, M333890, M371670, M384130, M396710, M399210, M399320, M399340, M403640, M412450, M421190, M423310, M424480, M451230, M457640, M461290, M468590, M470900, M473810, M487020, M511040, M545900, M545910, M547320, M560870, M570280, M570290, M585600, M585610, M586670, M594480, M600470, M609760, M611000, M632640, and M643150 |
|---|
Status history
No status changes recorded since RecallRadar first saw this recall on 2026-09-13 11:53 UTC. Current status: terminated.
Other recalls by Civco Medical Instruments
- eTRAX Needle Sensor - 16G(for Aurora Trackers), Part Number 667-158
FDA Device · Class II · 2026-04-08 · Civco Medical Instruments - eTRAX Needle System Starter Kit 12G (for Aurora Trackers), Part Number 667-149
FDA Device · Class II · 2026-04-08 · Civco Medical Instruments - eTRAX Needle Sensor - 14G(for Aurora Trackers), Part Number 667-157
FDA Device · Class II · 2026-04-08 · Civco Medical Instruments - eTRAX Needle System Starter Kit 14G (for Aurora Trackers), Part Number 667-150
FDA Device · Class II · 2026-04-08 · Civco Medical Instruments - eTRAX Needle System Starter Kit 16G(for Aurora Trackers), Part Number 667-151
FDA Device · Class II · 2026-04-08 · Civco Medical Instruments
All Civco Medical Instruments recalls
Source
Official record: https://api.fda.gov/device/enforcement.json?search=recall_number:%22Z-0289-2016%22
RecallRadar indexes public recall notices from the FDA, USDA FSIS, and CPSC. The official agency notice is the authoritative source. Always confirm details at the linked source before acting.