FDA Device recall Z-0369-2020
Pedia Prep: MD0033T - 4 oz tubes MD0033--SUP - Single Use Cups Skin preparation used to enhance signal quality of patient recording electro…
- FDA Device
- Class II
- terminated
- Published 2019-11-20
On 2019-11-20 the FDA classified a Class II recall of Pedia Prep: MD0033T - 4 oz tubes MD0033--SUP - Single Use Cups Skin preparation used to enhance signal quality of patient recording electro… by Carroll Baccari, citing product has the potential to be contaminated with Burholderia cepacia.
Read the official FDA Device notice
| Agency | FDA Device |
|---|---|
| Recall number | Z-0369-2020 |
| Classification | Class II |
| Status | terminated |
| Initiated | 2019-09-05 |
| Published | 2019-11-20 |
| Last updated | 2026-09-13 11:55 UTC |
| Company | Carroll Baccari |
| Distribution | n/a |
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.)
Reason
Product has the potential to be contaminated with Burholderia cepacia.
Identifiers
| code_info | MD0033T: 29769, 29915, 30067, 30643 MD0033-SUP: 29770,30027,30049, 30711 |
|---|
Status history
No status changes recorded since RecallRadar first saw this recall on 2026-09-13 11:55 UTC. Current status: terminated.
Source
Official record: https://api.fda.gov/device/enforcement.json?search=recall_number:%22Z-0369-2020%22
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