MicroCare Medical
United Statesfrom the FDA registration address FDA establishment FEI 1720499
- Devices
- 0
- Registrations
- FDA
- FDA recalls
- 11 ongoing
Company details
- FDA FEI number
- 1720499
- Address
- 6120 E. 58TH AVE., Commerce City, CO, 80022
FDA recalls
Recalls initiated per year
- 2017 0
- 2018 0
- 2019 0
- 2020 0
- 2021 0
- 2022 0
- 2023 0
- 2024 1
- 2025 0
- 2026 0
2024
- 29 Aug 2024 Z-3209-2024 Class II Ongoing Contaminated equipment and packaging caused Klebsiella oxytoca, Enterobacter asburiae, Enterobacter bugandensis, pathogenic and opportunistic bacteria, to occur in ultrasonic detergent, which caused product bloating/leaking, and if used during medical/dental procedures could result in urinary tract, respiratory, bloodstream infections; workers handling contaminated product/instruments also at risk
Full distribution text
- 29 Aug 2024 Z-3209-2024 Class II Ongoing Contaminated equipment and packaging caused Klebsiella oxytoca, Enterobacter asburiae, Enterobacter bugandensis, pathogenic and opportunistic bacteria, to occur in ultrasonic detergent, which caused product bloating/leaking, and if used during medical/dental procedures could result in urinary tract, respiratory, bloodstream infections; workers handling contaminated product/instruments also at risk