Recall Z-1550-2020 ยท KOY Degreaser, Skin, Surgical
Carroll-Baccari, Inc.
MVAP MEDICAL SUPPLIES INC, Mavidon CardioPrep Single, 24 use cups, Re order # MCP-24
| Date | Dec 23, 2019 |
| Status | Terminated |
| Reason | Samples of 114gm tubes of Lemon Prep, collected during a Food and Drug Administration inspection on October 15, 2019 were tested and found to be contaminated with Burkholderia cepacia. Mavidon is recalling all products manufactured at their facility. |
| Root cause | Under Investigation by firm |
| Action | The firm initiated the recall by issuing a public notice on 12/24/2019 then followed with recall letters on 12/26/2019. The firm followed with an amended recall notice disseminated on 01/07/2020, which removed the Collodion products, removers, and acetone. The letters requested the following actions: "1. Hospitals, distributors, and clinics that have any Mavidon products should immediately stop using the product and quarantine it. 2. Fill out the Medical Device Recall form below and email it to CS@mavidon.com 3. We will follow up and give instructions on how to return the product for credi |
| Quantity | 240 units |
| Distribution | Nationwide, Canada, UK, Spain, Australia |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
This recall record lists no 510(k) number.