Recall Z-0369-2020— Carroll-Baccari, Inc.

Name: FDA recall Z-0369-2020
Creator: U.S. Food and Drug Administration
Published: 2019-09-05

Class II · Terminated

Class II FDA medical device recall by Carroll-Baccari, Inc., initiated 2019-09-05, terminated 2021-10-19. FDA's recall record names no specific 510(k) clearance for this event. 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: Product has the potential to be contaminated with Burholderia cepacia..

Recalling firm: Carroll-Baccari, Inc.
Classification: Class II
Status: Terminated
Initiated: 2019-09-05
Terminated: 2021-10-19
Firm location: Riviera Beach, FL, United States

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.

Data sourced from openFDA. This site is unofficial and independent of the FDA.