Mavidon CardioPrep Single Recalled Due to Burkholderia cepacia Contamination
Carroll-Baccari, Inc. is recalling Mavidon CardioPrep Single products because samples were found contaminated with Burkholderia cepacia.
The agency’s classification
FDA (Devices): Class II
Class II is a situation in which use of or exposure to a violative product may cause temporary or medically reversible adverse health consequences, or where the probability of serious adverse health consequences is remote.
This is the agency’s own classification, taken from its notice. The severity score below is our assessment, not the agency’s. How recall classes work
What this means for you
Our assessment, not the agency’s: severity 3/5 (High).
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
Carroll-Baccari, Inc. is recalling Mavidon CardioPrep Single, 24 use cups (Re order # MCP-24). The recall involves 240 units distributed nationwide, as well as in Canada, the UK, Spain, and Australia.
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. Mavidon is recalling all products manufactured at their facility.
Consumers should stop using the recalled products and contact the recalling firm for further instructions.
The recalled product
- Product
- MVAP MEDICAL SUPPLIES INC, Mavidon CardioPrep Single, 24 use cups, Re order # MCP-24
- Manufacturer
- Carroll-Baccari, Inc.
- Hazard
- Affected units
- 240
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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