Mavidon Medical Prod
Flat Rock, NC, US
MAVIDON MEDICAL PROD appears in FDA device records in Flat Rock, NC. FDA records list no 510(k) clearances, no PMA records and one registered establishment. As of , FDA records show 6 recalls for this company, and at least one establishment registration is current.
FDA records held for this company
FDA records under these names
1 nameFDA records resolved to Mavidon Medical Prod carry these names as well, as FDA wrote them. Each is the firm named on a registration, a 510(k), a PMA, a recall or an enforcement report that was joined to this company on a shared FDA identifier or on a matching name.
- Carroll-Baccari, Inc.enforcement report, recall
510(k) clearance history
No 510(k) clearance records for this company in the ingested FDA data.
No 510(k) clearance records in the ingested FDA data.
Registered establishments
| Registration | FEI | Establishment | Address | Registration expires | Product codes listed |
|---|---|---|---|---|---|
| 3017189082 | 3017189082 | MAVIDON MEDICAL PROD | 110 Commercial Blvd, Flat Rock, NC 28731 US | 2026 |
Registration numbers link to the FDA registration and listing record for that establishment.
FDA product codes
Recall records
| Recall | Product | Reason | Classification | Initiated | Status |
|---|---|---|---|---|---|
| Z-1551-2020 | Wave Prep Tubes (1710-03) and single use cups (17--00-24) | 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. | Class II | Terminated | |
| Z-1550-2020 | MVAP MEDICAL SUPPLIES INC, Mavidon CardioPrep Single, 24 use cups, Re order # MCP-24 | 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. | Class II | Terminated | |
| Z-1549-2020 | PediaPrep Tubes (MD0033-T) and Single use cups (MD0033-SUP) | 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. | Class II | Terminated | |
| Z-1548-2020 | LemonPrep Tubes (MD0019-T) and Single use cups (MD0019-SUP) | 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. | Class II | Terminated | |
| Z-0369-2020 | 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.) | Product has the potential to be contaminated with Burholderia cepacia. | Class II | Terminated | |
| Z-0368-2020 | Lemon Prep: MD0019T - 4 oz tubes MD0019--SUP - Single Use Cups Skin preparation used to enhance signal quality of patient recording electrodes (i.e. EKG, ECG, etc.) | Product has the potential to be contaminated with Burholderia cepacia. | Class II | Terminated |
Verification record
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Data as of , FDA export datePage updated Source: openFDA, public domain