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Recall Observatory FDA recall evidence

Device 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.)

Z-0369-2020

September 05, 2019

Class II

Product summary

Firm
Carroll-Baccari, Inc.
Event
Event 83827
Status
Terminated
Classification
Class II
Quantity
2445 units
Official record key
device-enforcement:Z-0369-2020

Official wording

Reason: Product has the potential to be contaminated with Burholderia cepacia.

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

Distribution pattern: US, Canada, Spain, England, and Australia

Derived failure modes

  • Unknown

    reason.no_named_rule · v1.0.0

    Product has the potential to be contaminated with Burholderia cepacia.