Medical device recalls Moderate risk

Carroll-Baccari, Inc. recalls PediaPrep Tubes (MD0033-T) and Single use cups (MD0033-SUP)

Recall date
December 23, 2019
Source
U.S. Food & Drug Administration (FDA) — enforcement report
Recall number
Z-1549-2020
FDA classification
Class II
Brand / firm
Carroll-Baccari, Inc.
Sold / distributed
Nationwide, Canada, UK, Spain, Australia

Why it was recalled

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.

Class II means using this product may cause temporary or medically reversible health problems; the chance of serious harm is remote.

What was recalled

PediaPrep Tubes (MD0033-T) and Single use cups (MD0033-SUP)

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