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MADA MEDICAL PRODUCTS, INC.
MADA MEDICAL PRODUCTS, INC · Model 7000-MVP · UDI-DI 00815160021129
10
510(k) clearances
4,734
Adverse events (13 deaths)
107
Recalls
219
Facilities
Description
A portable assembly of devices, which includes a non-surgical invasive component, intended to manually aspirate unwanted materials (e.g., fluids, secretions) from the airway typically during patient transport or an emergency situation (e.g., placed on a crash cart). It includes a manually-powered (hand or foot-operated) suction pump, a collection container, and patient contact devices (e.g., handpiece/tip, mask), and typically also contains tubing and microbial/hydrophobic filters. The system is not intended for surgical use.
Recalls
| Date | Firm | Reason |
|---|---|---|
| 2018-11-05 | COVIDIEN LLC | The product was released into commercial distribution while subject to importation refusal. |
| 2017-04-21 | Cardinal Health 200, LLC | Product's seal possibly compromised, potentially compromising the sterility of the package contents. Use of impacted products could result in an increased risk of infection. |
| 2017-04-21 | Cardinal Health 200, LLC | Product's seal possibly compromised, potentially compromising the sterility of the package contents. Use of impacted products could result in an increased risk of infection. |
| 2017-04-21 | Cardinal Health 200, LLC | Product's seal possibly compromised, potentially compromising the sterility of the package contents. Use of impacted products could result in an increased risk of infection. |
| 2017-04-21 | Cardinal Health 200, LLC | Product's seal possibly compromised, potentially compromising the sterility of the package contents. Use of impacted products could result in an increased risk of infection. |
| 2017-04-21 | Cardinal Health 200, LLC | Product's seal possibly compromised, potentially compromising the sterility of the package contents. Use of impacted products could result in an increased risk of infection. |
| 2017-04-21 | Cardinal Health 200, LLC | Product's seal possibly compromised, potentially compromising the sterility of the package contents. Use of impacted products could result in an increased risk of infection. |
| 2017-04-21 | Cardinal Health 200, LLC | Product's seal possibly compromised, potentially compromising the sterility of the package contents. Use of impacted products could result in an increased risk of infection. |
| 2017-04-21 | Cardinal Health 200, LLC | Product's seal possibly compromised, potentially compromising the sterility of the package contents. Use of impacted products could result in an increased risk of infection. |
| 2017-04-21 | Cardinal Health 200, LLC | Product's seal possibly compromised, potentially compromising the sterility of the package contents. Use of impacted products could result in an increased risk of infection. |
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Get your free API keyRead the docsData compiled from public U.S. FDA sources (GUDID, 510(k)/PMA, MAUDE, recalls, establishment registration). Adverse-event reports are unverified and do not establish causation. Informational only — not medical, clinical, or regulatory advice.