PediaPrep Tubes — Class II medical device recall Z-1549-2020
Terminated recall by Carroll-Baccari, Inc., reported 2020-04-01, distributed nationwide. Samples of 114gm tubes of Lemon Prep, collected during a Food and Drug Administration inspection on October 15
| Recall number | Z-1549-2020 |
|---|---|
| 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 | 2019-12-23 |
| Classified | 2020-03-20 |
| Reported by FDA | 2020-04-01 |
| Terminated | 2021-09-28 |
| Distributed | Nationwide (US) |
| Countries outside the US | AU, CA, ES, GB |
| Quantity | 850 units |
| Pathogens | burkholderia |
Product
PediaPrep Tubes (MD0033-T) and Single use cups (MD0033-SUP)
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.
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-1549-2020. 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.