Home / Recalls / Carroll-Baccari, Inc. / Z-1549-2020

Z-1549-2020 Class II Terminated

Recalled by Carroll-Baccari, Inc. — Riviera Beach, FL

Recall Details

Product Type
Devices
Report Date
April 1, 2020
Initiation Date
December 23, 2019
Termination Date
September 28, 2021
Voluntary/Mandated
Voluntary: Firm initiated
Product Quantity
850 units

Product Description

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

Distribution Pattern

Nationwide, Canada, UK, Spain, Australia

Code Information

All Lots

Other recalls by Carroll-Baccari, Inc.

  • Z-1551-2020 Class II — Wave Prep Tubes (1710-03) and single use cups (17--00-24) (December 23, 2019)
  • Z-1550-2020 Class II — MVAP MEDICAL SUPPLIES INC, Mavidon CardioPrep Single, 24 use cups, Re order # M (December 23, 2019)
  • Z-1548-2020 Class II — LemonPrep Tubes (MD0019-T) and Single use cups (MD0019-SUP) (December 23, 2019)
  • Z-0368-2020 Class II — Lemon Prep: MD0019T - 4 oz tubes MD0019--SUP - Single Use Cups Skin prepara (September 5, 2019)
  • Z-0369-2020 Class II — Pedia Prep: MD0033T - 4 oz tubes MD0033--SUP - Single Use Cups Skin prepa (September 5, 2019)