FDA recall Z-0369-2020

Product

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

US, Canada, Spain, England, and Australia

Key facts

Status

Terminated

Initiation date

2019-09-05

Report date

2019-11-20

Termination date

2021-10-19

Voluntary/Mandated

Voluntary: Firm initiated

Location

Riviera Beach, FL, United States

Primary source

https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-0369-2020