Riviera Beach, FL, United States
Carroll-Baccari, Inc. recalls
2 recalls recorded since 2018, most recently on 23 December 2019. None are listed as ongoing. Status and classification are as published by the FDA.
Recalls2
Ongoing (FDA)0
Terminated or completed2
Class I (FDA)0
Terminated Class II Medical devices
- Recall started
- 23 December 2019
- Terminated
- 28 September 2021
- Reason
- 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.
- Distribution
- Nationwide, Canada, UK, Spain, Australia
- Initiated
- Voluntary: Firm initiated
- Recall numbers
- Z-1548-2020, Z-1551-2020, Z-1549-2020, Z-1550-2020
- LemonPrep Tubes (MD0019-T) and Single use cups (MD0019-SUP)
- Wave Prep Tubes (1710-03) and single use cups (17--00-24)
- PediaPrep Tubes (MD0033-T) and Single use cups (MD0033-SUP)
- MVAP MEDICAL SUPPLIES INC, Mavidon CardioPrep Single, 24 use cups, Re order # MCP-24
Terminated Class II Medical devices
- Recall started
- 5 September 2019
- Terminated
- 19 October 2021
- Reason
- Product has the potential to be contaminated with Burholderia cepacia.
- Distribution
- US, Canada, Spain, England, and Australia
- Initiated
- Voluntary: Firm initiated
- Recall numbers
- Z-0369-2020, Z-0368-2020
- 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.)
- 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.)
A terminated FDA recall means the FDA has determined that all reasonable efforts to remove or correct the product have been made. What statuses mean.