Carroll-Baccari, Inc. recalls Pedia Prep: MD0033T - 4 oz tubes MD0033--SUP - Single Use Cups Skin preparation used to enhance signal quality of patie…
- Recall date
- September 5, 2019
- Source
- U.S. Food & Drug Administration (FDA) — enforcement report
- Recall number
- Z-0369-2020
- FDA classification
- Class II
- Brand / firm
- Carroll-Baccari, Inc.
- Sold / distributed
- US, Canada, Spain, England, and Australia
Why it was recalled
Product has the potential to be contaminated with Burholderia cepacia.
Class II means using this product may cause temporary or medically reversible health problems; the chance of serious harm is remote.
What was recalled
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.)
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