Recall Z-0369-2020 ยท KOY Degreaser, Skin, Surgical
Carroll-Baccari, Inc.
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.)
| Date | Sep 5, 2019 |
| Status | Terminated |
| Reason | Product has the potential to be contaminated with Burholderia cepacia. |
| Root cause | Material/Component Contamination |
| Action | The firm initiated the recall of Lemon Prep by email on 09/05/2019. Distributors were directed to notify their customers and ask them to contact Mavidon directly. Direct accounts were asked to cease use and contact the company for replacement. The firm issued a press release on 09/30/2019 and posted a copy along with a copy of the recall notice on their website. The firm initiated the recall of its Pedia Prep on 10/08/2019 by email and posted a copy of the recall letter on its website. |
| Quantity | 2445 units |
| Distribution | US, Canada, Spain, England, and Australia |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
This recall record lists no 510(k) number.