FDA-Device2019-11-20Class II
Pedia Prep: MD0033T - 4 oz tubes MD0033--SUP - Single Use Cups Skin preparation used to enhance signal quality of patient recording electrodes (i.e. EKG, ECG, etc.)
Hazard
Product has the potential to be contaminated with Burholderia cepacia.
Sold states
US, Canada, Spain, England, and Australia
Affected count
2445 units
Manufactured in
6625 White Dr, N/A, Riviera Beach, FL, United States
Products
Pedia Prep: MD0033T - 4 oz tubes MD0033--SUP - Single Use Cups Skin preparation used to enhance signal quality of patient recording electrodes (i.e. EKG, ECG, etc.)
Official notice
https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-0369-2020Don't want to check this manually?
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