CLASS II Device recall · Reported 20 Nov 2019 · FDA Enforcement Report
Pedia Prep: MD0033T - tubes MD0033--SUP recalled by Carroll-Baccari
Carroll-Baccari is recalling Pedia Prep: MD0033T - tubes MD0033--SUP - Single Use Cups Skin preparation used to. The recall was initiated on 5 Sep 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-0369-2020
- FDA event ID
- 83827
- Recalling firm
- Carroll-Baccari, Riviera Beach, FL
- Classification
- Class II
- Status
- Terminated
- Recall initiated
- 5 Sep 2019
- FDA classified
- 13 Nov 2019
- Reported
- 20 Nov 2019
- Type
- Voluntary: Firm initiated
- Customers notified by
- Reason category
- Other Reasons
- Device type
- Patient Monitors
Timeline
| 5 Sep 2019 | Recall initiated by company | |
| 13 Nov 2019 | Classified by FDA | +69 days |
| 20 Nov 2019 | Published in enforcement report | +7 days |
Companies usually start a recall weeks before the FDA classifies and publishes it; the gap above is that lag.
Reason for recall
Product has the potential to be contaminated with Burholderia cepacia.
Product as listed by the FDA
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.)
Where it was distributed
US, Canada, Spain, England, and Australia
Questions about this recall
Why was it recalled?
Product has the potential to be contaminated with Burholderia cepacia.
Which lots are affected?
MD0033T: 29769, 29915, 30067, 30643 MD0033-SUP: 29770,30027,30049, 30711
Where was it sold?
US, Canada, Spain, England, and 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 26 Sep 2026. The FDA describes openFDA data as unvalidated; the official notice takes precedence. This page reports the record and gives no medical advice.
Other products in this recall event
1 other product · FDA event 83827| Reported | Class | Recall | Company | Reason | Where |
|---|---|---|---|---|---|
| CLASS II | Lemon Prep: MD0019T - tubes MD0019--SUP recalled by Carroll-Baccari | Carroll-Baccari | Other | FL |
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 | LemonPrep Tubes (MD0019-T) and Single use cups (MD0019-SUP) recalled | Carroll-Baccari | Sterility | Nationwide |
| Device | CLASS II | Lemon Prep: MD0019T - tubes MD0019--SUP recalled by Carroll-Baccari | Carroll-Baccari | Other | FL |
Other Patient Monitors recalls
All 1,013| Reported | Class | Recall | Company | Reason | Where |
|---|---|---|---|---|---|
| Device | CLASS I | Bravo CF capsule delivery device, Product Number FGS recalled | Given Imaging | Device Malfunction | Nationwide |
| Device | CLASS II | Lux-Dx, Lux-Dx II, Lux-Dx II+ Insertable Cardiac Monitor recalled | Boston Scientific | Device Malfunction | Nationwide |
| Device | CLASS II | Lux-Dx, Lux-Dx II, Lux-Dx II+ Insertable Cardiac Monitor recalled | Boston Scientific | Device Malfunction | Nationwide |
| Device | CLASS II | Lux-Dx, Lux-Dx II, Lux-Dx II+ Insertable Cardiac Monitor recalled | Boston Scientific | Device Malfunction | Nationwide |
| Device | CLASS II | IQecg Digital ECG recalled by Midmark | Midmark | Labeling Errors | Nationwide |