FDA Device recall Z-0290-2016
CIVCO Sales Demo Kit
- FDA Device
- Class II
- terminated
- Published 2015-11-25
On 2015-11-25 the FDA classified a Class II recall of CIVCO Sales Demo Kit by Civco Medical Instruments, citing sterility of the product cannot be assured.
Read the official FDA Device notice
| Agency | FDA Device |
|---|---|
| Recall number | Z-0290-2016 |
| 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 Sales Demo Kit. REF DEMOGPGUIDE 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 | M116270, M119900, M121920, M125640, M130290, M170900, M185950, M204790, M211280, M215550, M235410, M240880, M252870, M3…M116270, M119900, M121920, M125640, M130290, M170900, M185950, M204790, M211280, M215550, M235410, M240880, M252870, M303130, M320620, M320660, M346050, M368820, M379870, M391260, M395270, M418200, M476020, M497220, M508200, M594740, M598320, and M624430 |
|---|
Status history
No status changes recorded since RecallRadar first saw this recall on 2026-09-13 11:53 UTC. Current status: terminated.
Source
Official record: https://api.fda.gov/device/enforcement.json?search=recall_number:%22Z-0290-2016%22
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