Z-0369-2020 Class II Terminated
FDA device recall Z-0369-2020 was initiated by Carroll-Baccari, Inc. on September 5, 2019 and is designated Class II. Reason for recall: Product has the potential to be contaminated with Burholderia cepacia. The recall status is terminated (terminated October 19, 2021). Affected quantity: 2445 units.
Recall Details
- Product Type
- Devices
- Report Date
- November 20, 2019
- Initiation Date
- September 5, 2019
- Termination Date
- October 19, 2021
- Voluntary/Mandated
- Voluntary: Firm initiated
- Product Quantity
- 2445 units
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.
Distribution Pattern
US, Canada, Spain, England, and Australia
Code Information
MD0033T: 29769, 29915, 30067, 30643 MD0033-SUP: 29770,30027,30049, 30711