FDA recall Z-1550-2020

Carroll-Baccari, Inc. · Class II · device

Product

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

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.

Distribution

Nationwide, Canada, UK, Spain, Australia

Key facts

Status: Terminated
Initiation date: 2019-12-23
Report date: 2020-04-01
Termination date: 2021-09-28
Voluntary/Mandated: Voluntary: Firm initiated
Location: Riviera Beach, FL, United States

Primary source

https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-1550-2020