Mavidon Recalls PediaPrep Tubes and Cups Due to Bacterial Contamination
Mavidon is recalling PediaPrep Tubes and Single use cups because samples were found contaminated with Burkholderia cepacia during an FDA inspection.
What this means for you
Real risk of harm even if no illness or injury has been reported yet. Stop using the product and follow the agency's guidance.
Our severity reasoning: The recall involves a high-risk pathogen (Burkholderia cepacia) without reported illness, which aligns with the 'High' severity criteria for high-risk pathogens without reported illness.
Plain-English summary
Mavidon is voluntarily recalling PediaPrep Tubes (MD0033-T) and Single use cups (MD0033-SUP). The recall was initiated after 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.
The recall covers all products manufactured at the Mavidon facility. The source text does not specify the exact number of units, specific lot numbers, or the geographic distribution of the affected products.
Consumers should stop using the recalled products and contact Mavidon for instructions on how to return or dispose of them.
The recalled product
- Product
- PediaPrep Tubes (MD0033-T) and Single use cups (MD0033-SUP)
- Manufacturer
- Carroll-Baccari, Inc.
- Hazard
- Affected units
- 850
Is your product affected?
Check your packaging against the codes below. If any of them match, the product is part of this recall.
Lot numbers (1)
- All Lots
Distribution
Distributed nationwide across the United States.
Part of a larger recall action
This product is one of 4 recalled by Carroll-Baccari, Inc. under a single FDA (Devices) recall action. The agency files each product separately, so the size of the action is not visible from this page alone.
See all 4 products in this recall →Related recalls
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- HighCarroll-Baccari Lemon Prep Skin Preparation Recalled for Potential Contamination
FDA (Devices) · 2019-11-20
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