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Recall Observatory FDA recall evidence

Device product

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

Z-1549-2020

December 23, 2019

Class II

Product summary

Firm
Carroll-Baccari, Inc.
Event
Event 84587
Status
Terminated
Classification
Class II
Quantity
850 units
Official record key
device-enforcement:Z-1549-2020

Official wording

Reason: 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.

Code information: All Lots

Distribution pattern: Nationwide, Canada, UK, Spain, Australia

Derived failure modes

  • Microbial contamination

    reason.microbial_contamination · v1.0.0

    found to be contaminated with Burkholderia cepacia