Carroll-Baccari, Inc.: Medical Device Recall in 2019 - (Recall #: Z-0369-2020)

Updated on March 25, 2026.

See the recall detail below. You can also see other recalls from the same firm in 2019.

Data Source: FDA.

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.)

Product Classification:

Class II

Date Initiated: September 5, 2019

Date Posted: November 20, 2019

Recall Number: Z-0369-2020

Event ID: 83827

Reason for Recall:

Product has the potential to be contaminated with Burholderia cepacia.

Status: Terminated

Product Quantity: 2445 units

Code Information:

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

Distribution Pattern:

US, Canada, Spain, England, and Australia

Voluntary or Mandated:

Voluntary: Firm initiated