MVAP MEDICAL SUPPLIES INC, Mavidon CardioPrep Single, 24 use cups, Re order # MCP-24

FDA Recall #Z-1550-2020 — Class II — December 23, 2019

Recall #Z-1550-2020 Date: December 23, 2019 Classification: Class II Status: Terminated

Product Description

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

240 units

Distribution

Nationwide, Canada, UK, Spain, Australia

Code Information

All Lots

Status

Terminated

Voluntary / Mandated

Voluntary: Firm initiated

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