FDADecember 23, 2019device
Wave Prep Tubes (1710-03) and single use cups (17--00-24)
Official recall recorded by the U.S. Food & Drug Administration.
The hazard
Samples of 114gm tubes of Lemon Prep, collected during a Food and Drug Administration inspection on October 15, 2019 were tested and found to be contaminated with Burkholderia cepacia. Mavidon is recalling all products manufactured at their facility.
What to do
FDA enforcement status: Terminated
Brands named
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Recall history
Other federal recalls tied to the same brand — a factual pattern, straight from the source data.
- FDALemonPrep Tubes (MD0019-T) and Single use cups (MD0019-SUP)2019-12-23
- FDAPediaPrep Tubes (MD0033-T) and Single use cups (MD0033-SUP)2019-12-23
- FDAMVAP MEDICAL SUPPLIES INC, Mavidon CardioPrep Single, 24 use cups, Re order # MCP-242019-12-23
- FDALemon 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.)2019-09-05
- FDAPedia 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.)2019-09-05
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