Carroll-Baccari Recalls LemonPrep Tubes and Cups Due to Bacterial Contamination
Carroll-Baccari, Inc. is recalling LemonPrep Tubes and Single use cups because samples tested positive for 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 risk-of-harm products where injury has not yet been reported.
Plain-English summary
Carroll-Baccari, Inc. is recalling 8,030 units of LemonPrep Tubes (MD0019-T) and Single use cups (MD0019-SUP). The recall covers all lots of these products.
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 source text notes that Mavidon is recalling all products manufactured at their facility.
The affected products were distributed nationwide, as well as in Canada, the UK, Spain, and Australia. Consumers should stop using these products and follow the instructions provided by the recalling firm.
The recalled product
- Product
- LemonPrep Tubes (MD0019-T) and Single use cups (MD0019-SUP)
- Manufacturer
- Carroll-Baccari, Inc.
- Category
- Medical Device — Surgical Prep
- Hazard
- Affected units
- 8,030
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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