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Civco Medical Instruments Co. Inc. FDA Recalls
13 recalls on file across devices, 0 of them Class I and 9 still open. This firm is not matched to a listed company.
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Class I is the FDA's most serious grade: a reasonable probability of serious harm or death.
| Product |
|---|
| eTRAX Needle System Starter Kit 12G (for Aurora Trackers), Part Number 667-149Class IIMar 2, 2026There was an error in inspection and programming of the eTRA |
| eTRAX Needle System Starter Kit 18G (for Aurora Trackers), Part Number 667-152Class IIMar 2, 2026There was an error in inspection and programming of the eTRA |
| eTRAX Needle Sensor - 12G (for Aurora Trackers), Part Number 667-156Class IIMar 2, 2026There was an error in inspection and programming of the eTRA |
| eTRAX Needle System Starter Kit 16G(for Aurora Trackers), Part Number 667-151Class IIMar 2, 2026There was an error in inspection and programming of the eTRA |
| eTRAX Needle Sensor - 18G (for Aurora Trackers), Part Number 667-159Class IIMar 2, 2026There was an error in inspection and programming of the eTRA |
| eTRAX Needle System Starter Kit 14G (for Aurora Trackers), Part Number 667-150Class IIMar 2, 2026There was an error in inspection and programming of the eTRA |
| eTRAX Needle Sensor - 14G(for Aurora Trackers), Part Number 667-157Class IIMar 2, 2026There was an error in inspection and programming of the eTRA |
| eTRAX Needle Sensor - 16G(for Aurora Trackers), Part Number 667-158Class IIMar 2, 2026There was an error in inspection and programming of the eTRA |
| BX2 Needle Guide, Part Number 644-094, tool for performing needle-guided (or catheter) procedures with the use of diagnoClass IIMay 1, 2025During the attachment of the needle guide to the covered pro |
| VirtuTRAX Instrument Navigator, 10 17 GA VirtuTRAXClass IIOct 8, 2021There is potential that the VirtuTRAX device will not tighte |
| VirtuTRAX Instrument Navigator, Sensor with 10 17 GA VirtutTRAXClass IIOct 8, 2021There is potential that the VirtuTRAX device will not tighte |
| VirtuTRAX Instrument Navigator, 14 Ga VirtuTRAXClass IIOct 8, 2021There is potential that the VirtuTRAX device will not tighte |
| VirtuTRAX Instrument Navigator, Sensor with 14 Ga VirtutTRAXClass IIOct 8, 2021There is potential that the VirtuTRAX device will not tighte |