LemonPrep Tubes (MD0019-T) and Single use cups (MD0019-SUP)
FDA Recall #Z-1548-2020 — Class II — December 23, 2019
Product Description
LemonPrep Tubes (MD0019-T) and Single use cups (MD0019-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.
Recalling Firm
Carroll-Baccari, Inc. — Riviera Beach, FL
Classification
Class II — May cause temporary or medically reversible adverse health consequences.
Product Type
Devices
Product Quantity
8030 units
Distribution
Nationwide, Canada, UK, Spain, Australia
Code Information
All Lots
Status
Terminated
Voluntary / Mandated
Voluntary: Firm initiated