Lemon Prep: MD0019T — Class II medical device recall Z-0368-2020
Terminated recall by Carroll-Baccari, Inc., reported 2019-11-20. Product has the potential to be contaminated with Burholderia cepacia.
| Recall number | Z-0368-2020 |
|---|---|
| Product type | Medical device |
| Classification | Class II |
| Status | Terminated |
| Voluntary or mandated | Voluntary |
| Recalling firm | Carroll-Baccari, Inc., Riviera Beach, FL, United States |
| Recall initiated | 2019-09-05 |
| Classified | 2019-11-13 |
| Reported by FDA | 2019-11-20 |
| Terminated | 2021-10-19 |
| Countries outside the US | AU, CA, ES, GB |
| Quantity | 24,979 units |
Product
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.)
Reason for recall
Product has the potential to be contaminated with Burholderia cepacia.
Machine access
This record, with every extracted code, the verbatim FDA record and provenance, is available from the recall API: GET https://api.data.aroqon.com/v1/recalls/Z-0368-2020. Look up any UPC, UDI, NDC or lot with /v1/recalls/lookup?code=…. API docs · free and paid keys.
Source: U.S. Food and Drug Administration enforcement report via openFDA (CC0). Structured by Data Foundry (recall-structuring@2); last changed 2026-09-26. Not affiliated with or endorsed by FDA. Not medical or legal advice.