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MADA MEDICAL PRODUCTS
MADA MEDICAL PRODUCTS, INC · Model 7022 · UDI-DI 00815160020719
10
510(k) clearances
1,864
Adverse events (4 deaths)
17
Recalls
374
Facilities
Description
A substance containing a chemical agent(s) intended to destroy harmful microorganisms or inhibit their activity on a medical device (e.g., surgical or dental instrument); it may also contain surfactants/cleaning agents or biological enzymes (e.g. protease, lipase, amylase). The medical device is intended to be exposed to the substance for a specified period of time to achieve disinfection, through bathing, wiping, and/or in combination with a disinfection system/unit; it is not supplied as an aerosol and does not include a wipe.
Recalls
| Date | Firm | Reason |
|---|---|---|
| 2026-06-30 | Medline Industries, LP | Medline Micro-Kill Bleach Germicidal Bleach Wipes may exhibit a reduction in bleach concentration to levels below specification prior to the end of the labeled 12-month shelf life. |
| 2026-06-30 | Medline Industries, LP | Medline Micro-Kill Bleach Germicidal Bleach Wipes may exhibit a reduction in bleach concentration to levels below specification prior to the end of the labeled 12-month shelf life. |
| 2026-06-30 | Medline Industries, LP | Medline Micro-Kill Bleach Germicidal Bleach Wipes may exhibit a reduction in bleach concentration to levels below specification prior to the end of the labeled 12-month shelf life. |
| 2026-06-30 | Medline Industries, LP | Medline Micro-Kill Bleach Germicidal Bleach Wipes may exhibit a reduction in bleach concentration to levels below specification prior to the end of the labeled 12-month shelf life. |
| 2023-12-20 | MEDLINE INDUSTRIES, LP - Northfield | There is stability concern for products dated with a 24-month shelf life. Product is safe and effective up to 12 months shelf life. |
| 2022-06-29 | MEDLINE INDUSTRIES, LP - Northfield | stability failure |
| 2022-05-25 | Mckesson Medical-Surgical Inc. Corporate Office | Facility Temperature excursions (from June 2021-August 2021) prior to delivery; exposure to higher temperatures may have impacted product effectiveness. All lots received between 0 |
| 2022-05-25 | Mckesson Medical-Surgical Inc. Corporate Office | Facility Temperature excursions (from June 2021-August 2021) prior to delivery; exposure to higher temperatures may have impacted product effectiveness. All lots received between 0 |
| 2022-05-25 | Mckesson Medical-Surgical Inc. Corporate Office | Facility Temperature excursions (from June 2021-August 2021) prior to delivery; exposure to higher temperatures may have impacted product effectiveness. All lots received between 0 |
| 2021-12-29 | MEDLINE INDUSTRIES, LP - Northfield | Micro-Kill Bleach Wipes contain out of specification (low) levels of Sodium Hypochlorite. |
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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.