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Recall Observatory FDA recall evidence

Device 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.)

Z-0368-2020

September 05, 2019

Class II

Product summary

Firm
Carroll-Baccari, Inc.
Event
Event 83827
Status
Terminated
Classification
Class II
Quantity
24,979 units
Official record key
device-enforcement:Z-0368-2020

Official wording

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

Code information: 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

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.