CLASS II Device recall · Reported 1 Apr 2020 · FDA Enforcement Report
LemonPrep Tubes (MD0019-T) and Single use cups (MD0019-SUP) recalled
Carroll-Baccari is recalling LemonPrep Tubes (MD0019-T) and Single use cups (MD0019-SUP), distributed nationwide in the US. The recall was initiated on 23 Dec 2019 and the FDA has classified it as Class II.
Check your package
Stop using the device if the notice says to, and contact the manufacturer or your healthcare provider for the correction or replacement.
Recall details
- Recall number
- Z-1548-2020
- FDA event ID
- 84587
- Recalling firm
- Carroll-Baccari, Riviera Beach, FL
- Classification
- Class II
- Status
- Terminated
- Recall initiated
- 23 Dec 2019
- FDA classified
- 20 Mar 2020
- Reported
- 1 Apr 2020
- Type
- Voluntary: Firm initiated
- Customers notified by
- Press Release
- Reason category
- Sterility
- Device type
- Other Medical Devices
Timeline
| 23 Dec 2019 | Recall initiated by company | |
| 20 Mar 2020 | Classified by FDA | +88 days |
| 1 Apr 2020 | Published in enforcement report | +12 days |
Companies usually start a recall weeks before the FDA classifies and publishes it; the gap above is that lag.
Reason for recall
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.
A sterility recall means a product that must be sterile, such as an injection or eye drop, may be contaminated. Using a non-sterile product can cause serious infection.
Product as listed by the FDA
LemonPrep Tubes (MD0019-T) and Single use cups (MD0019-SUP)
Where it was distributed
Nationwide, Canada, UK, Spain, Australia
Questions about this recall
Is LemonPrep Tubes (MD0019-T) and Single use cups (MD0019-SUP) recalled?
Yes. Carroll-Baccari recalled LemonPrep Tubes (MD0019-T) and Single use cups (MD0019-SUP) on 23 Dec 2019. The recall is Class II and its status is Terminated. Recall number Z-1548-2020.
Why was it recalled?
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.
Which lots are affected?
All Lots
Where was it sold?
Nationwide, Canada, UK, Spain, Australia
What should I do if I have it?
Stop using the device if the notice says to, and contact the manufacturer or your healthcare provider for the correction or replacement.
What does Class II mean?
Class II means the product may cause temporary or medically reversible health problems, or the probability of serious harm is remote.
Read the official FDA notice · Source record retrieved 21 Sep 2026. The FDA describes openFDA data as unvalidated; the official notice takes precedence. This page reports the record and gives no medical advice.
More recalls from Carroll-Baccari
All 6| Reported | Class | Recall | Company | Reason | Where |
|---|---|---|---|---|---|
| Device | CLASS II | Mvap Medical Supplies Inc, Mavidon CardioPrep Single recalled | Carroll-Baccari | Sterility | Nationwide |
| Device | CLASS II | PediaPrep Tubes (MD0033-T) and Single use cups (MD0033-SUP) recalled | Carroll-Baccari | Sterility | Nationwide |
| Device | CLASS II | Wave Prep Tubes (1710-03) and single use cups (17--00-24) recalled | Carroll-Baccari | Sterility | Nationwide |
| Device | CLASS II | Lemon Prep: MD0019T - tubes MD0019--SUP recalled by Carroll-Baccari | Carroll-Baccari | Other | FL |
| Device | CLASS II | Pedia Prep: MD0033T - tubes MD0033--SUP recalled by Carroll-Baccari | Carroll-Baccari | Other | FL |
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