FDADecember 3, 2024device
ECONO STERILE medical procedure kits labeled as: 1) ECONO STERILE PROBE W/EYE CS/50, Model Number 94-5923; 2) ECONO STERIL" PROBE W/EYE 5.5" STERL CS/25, Model Number 96-2361; orthopedic probe
Official recall recorded by the U.S. Food & Drug Administration.
The hazard
Reports of various packaging issues that may result in a breach of the sterile barrier.
What to do
FDA enforcement status: Ongoing
Brands named
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UPCs
5064911118166350649111392601
Recall history
Other federal recalls tied to the same brand — a factual pattern, straight from the source data.
- FDAeTRAX Needle Sensor - 16G(for Aurora Trackers), Part Number 667-1582026-03-02
- FDAeTRAX Needle Sensor - 18G (for Aurora Trackers), Part Number 667-1592026-03-02
- FDAeTRAX Needle Sensor - 12G (for Aurora Trackers), Part Number 667-1562026-03-02
- FDAeTRAX Needle System Starter Kit 16G(for Aurora Trackers), Part Number 667-1512026-03-02
- FDAeTRAX Needle Sensor - 14G(for Aurora Trackers), Part Number 667-1572026-03-02
- FDAeTRAX Needle System Starter Kit 18G (for Aurora Trackers), Part Number 667-1522026-03-02
- FDAeTRAX Needle System Starter Kit 14G (for Aurora Trackers), Part Number 667-1502026-03-02
- FDAeTRAX Needle System Starter Kit 12G (for Aurora Trackers), Part Number 667-1492026-03-02
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