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.)
Reported: November 20, 2019 Initiated: September 5, 2019 #Z-0369-2020
Product Description
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.)
Reason for Recall
Product has the potential to be contaminated with Burholderia cepacia.
Details
- Recalling Firm
- Carroll-Baccari, Inc.
- Units Affected
- 2445 units
- Distribution
- US, Canada, Spain, England, and Australia
- Location
- Riviera Beach, FL
Frequently Asked Questions
What product was recalled? ▼
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.). Recalled by Carroll-Baccari, Inc.. Units affected: 2445 units.
Why was this product recalled? ▼
Product has the potential to be contaminated with Burholderia cepacia.
Which agency issued this recall? ▼
This recall was issued by the FDA Devices on November 20, 2019. Severity: Moderate. Recall number: Z-0369-2020.
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