The Recall Desk
HighFDA (Devices)·Z-0369-2020·Announced 2019-11-20

Carroll-Baccari Recalls Pedia Prep Skin Preparation Due to Contamination Risk

Carroll-Baccari, Inc. is recalling Pedia Prep skin preparation products due to potential contamination with Burholderia cepacia. The recall affects 2,445 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 high-risk pathogen (Burholderia cepacia) without reported illness, which aligns with the 'High' severity criteria for risk-of-harm products where injury has not yet been reported.

Plain-English summary

Carroll-Baccari, Inc. is recalling Pedia Prep skin preparation products, specifically 4 oz tubes (MD0033T) and Single Use Cups (MD0033-SUP). These products are used to enhance the signal quality of patient recording electrodes, such as those used for EKG or ECG monitoring. The recall involves 2,445 units with specific lot codes: MD0033T (29769, 29915, 30067, 30643) and MD0033-SUP (29770, 30027, 30049, 30711).

The recall was initiated because the product has the potential to be contaminated with Burholderia cepacia. This is a bacterium that can cause infections, particularly in individuals with compromised immune systems or those with indwelling medical devices. The affected units were distributed in the United States, Canada, Spain, England, and Australia.

Consumers and healthcare facilities should stop using the affected Pedia Prep products immediately. Users should check their inventory for the specific lot codes listed above. If you have questions regarding this recall or need assistance, please contact Carroll-Baccari, Inc. directly.

The recalled product

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.)
Manufacturer
Carroll-Baccari, Inc.
Category
Medical Device — Skin Preparation
Hazard
Affected units
2,445

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 (7)

  • MD0033T: 29769
  • 29915
  • 30067
  • 30643 MD0033-SUP: 29770
  • 30027
  • 30049
  • 30711

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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