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Terminated

PediaPrep Tubes (MD0033-T) and Single use cups (MD0033-SUP)

FDA Recall Z-1549-2020 · Posted None

Recalling FirmCarroll-Baccari, Inc.
Recall StatusTerminated
Product CodeKOY
Date Initiated2019-12-23
Date Terminated2021-09-28
Product Quantity850 units

Reason for Recall

Samples of 114gm tubes of Lemon Prep, collected during a Food and Drug Administration inspection on October 15, 2019 were tested and found to be contaminated with Burkholderia cepacia. Mavidon is recalling all products manufactured at their facility.

Firm Action

The firm initiated the recall by issuing a public notice on 12/24/2019 then followed with recall letters on 12/26/2019. The firm followed with an amended recall notice disseminated on 01/07/2020, which removed the Collodion products, removers, and acetone. The letters requested the following actions: "1. Hospitals, distributors, and clinics that have any Mavidon products should immediately stop using the product and quarantine it. 2. Fill out the Medical Device Recall form below and email it to [email protected] 3. We will follow up and give instructions on how to return the product for credit." Contact Mavidon at 800-654-0385 or by email to [email protected]

Root Cause

Under Investigation by firm

Distribution Pattern

Nationwide, Canada, UK, Spain, Australia

Official Source

View FDA Recall →

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

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