Home / Recalls / Carroll-Baccari, Inc. / Z-0369-2020

Z-0369-2020 Class II Terminated

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

Recall Details

Product Type
Devices
Report Date
November 20, 2019
Initiation Date
September 5, 2019
Termination Date
October 19, 2021
Voluntary/Mandated
Voluntary: Firm initiated
Product Quantity
2445 units

Product Description

Pedia Prep: MD0033T - 4 oz tubes MD0033--SUP - Single Use Cups Skin preparation used to enhance signal quality of patient recording electrodes (i.e. EKG, ECG, etc.)

Reason for Recall

Product has the potential to be contaminated with Burholderia cepacia.

Distribution Pattern

US, Canada, Spain, England, and Australia

Code Information

MD0033T: 29769, 29915, 30067, 30643 MD0033-SUP: 29770,30027,30049, 30711

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-1549-2020 Class II — PediaPrep Tubes (MD0033-T) and Single use cups (MD0033-SUP) (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)