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Terminated

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.)

FDA Recall Z-0369-2020 · Posted None

Recalling FirmCarroll-Baccari, Inc.
Recall StatusTerminated
Product CodeKOY
Date Initiated2019-09-05
Date Terminated2021-10-19
Product Quantity2445 units

Reason for Recall

Product has the potential to be contaminated with Burholderia cepacia.

Firm Action

The firm initiated the recall of Lemon Prep by email on 09/05/2019. Distributors were directed to notify their customers and ask them to contact Mavidon directly. Direct accounts were asked to cease use and contact the company for replacement. The firm issued a press release on 09/30/2019 and posted a copy along with a copy of the recall notice on their website. The firm initiated the recall of its Pedia Prep on 10/08/2019 by email and posted a copy of the recall letter on its website.

Root Cause

Material/Component Contamination

Distribution Pattern

US, Canada, Spain, England, and Australia

Official Source

View FDA Recall →

Source: FDA Enforcement Report / Recall database. Always confirm against the official FDA record.

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