FDA-Device2019-11-20Class II

Lemon Prep: MD0019T - 4 oz tubes MD0019--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
24,979 units
Manufactured in
6625 White Dr, N/A, Riviera Beach, FL, United States
Products
Lemon Prep: MD0019T - 4 oz tubes MD0019--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-0368-2020

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