Carroll-Baccari, Inc.: Product has the potential to be contaminated with Burholderia cepacia.

Agency Publication Date: November 13, 2019

Affected Products

Product: Lemon Prep: MD0019T - 4 oz tubes MD0019--SUP - Single Use Cups Skin preparation used to enhance signal quality of patient recording electrodes (i.e. EKG, ECG, etc.)

MD0019-T: 29824, 29901, 30006, 30145, 30236, 30352, 30675, 30729, 31138 MD0019-SUP: 29927, 30009, 30031, 30115, 30059, 30237, 30300, 30340, 30424, 30642, 30735, 31139

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.)

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

Additional Information

Agency: Food and Drug Administration (FDA)

Event ID: 83827

Status: Resolved

Manufacturer: Carroll-Baccari, Inc.

Manufactured In: United States

Units Affected: 2 products (24,979 units; 2445 units)

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AI-Enhanced Content: The summary, action steps, and risk assessment on this page were generated by AI from official government recall data to improve readability. This is not legal or medical advice. Always refer to the official agency sources below for authoritative information.

Sources: FDA iRES · Raw API Response

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Medium RiskFDA Device