The Recall Desk
HighFDA (Devices)·Z-0368-2020·Announced 2019-11-20

Carroll-Baccari Lemon Prep Skin Preparation Recalled for Potential Contamination

Carroll-Baccari, Inc. is recalling Lemon Prep skin preparation products due to potential contamination with Burholderia cepacia. The recall affects 24,979 units distributed in the US, Canada, Spain, England, and Australia.

What this means for you

Real risk of harm even if no illness or injury has been reported yet. Stop using the product and follow the agency's guidance.

Our severity reasoning: The recall involves a medical device with a potential contamination by a pathogen (Burholderia cepacia) without reported illnesses or injuries, fitting the 'High' severity criteria for risk-of-harm products where injury has not yet been reported.

Plain-English summary

Carroll-Baccari, Inc. is recalling specific lots of Lemon Prep, a skin preparation product used to enhance the signal quality of patient recording electrodes such as EKG and ECG. The recall is being conducted because the product has the potential to be contaminated with Burholderia cepacia.

The affected products include 4 oz tubes (MD0019T) and Single Use Cups (MD0019--SUP). A total of 24,979 units are involved in this recall. The products were distributed in the United States, Canada, Spain, England, and Australia.

Consumers and healthcare facilities should stop using the affected products immediately. The specific lot codes for the 4 oz tubes are 29824, 29901, 30006, 30145, 30236, 30352, 30675, 30729, and 31138. The specific lot codes for the Single Use Cups are 29927, 30009, 30031, 30115, 30059, 30237, 30300, 30340, 30424, 30642, 30735, and 31139. Users should contact Carroll-Baccari, Inc. for further instructions on how to return or dispose of the recalled items.

The recalled product

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.)
Manufacturer
Carroll-Baccari, Inc.
Category
Medical Device — Skin Preparation
Hazard
Affected units
24,979

Is your product affected?

Check your packaging against the codes below. If any of them match, the product is part of this recall.

Lot numbers (20)

  • 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

Distribution scope not specified by the agency.

Part of a larger recall action

This product is one of 2 recalled by Carroll-Baccari, Inc. under a single FDA (Devices) recall action. The agency files each product separately, so the size of the action is not visible from this page alone.

See all 2 products in this recall →

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