Anasept Antimicrobial Skin and Wound Cleanser
ANACAPA TECHNOLOGIES, INC. · Model 4004SC · UDI-DI 00367180400441
Description
Anasept® Antimicrobial Skin and Wound Cleanser is a clear, isotonic liquid that helps in the mechanical removal of the debris from the application site; while delivering 0.057% broad spectrum antimicrobial sodium hypochlorite. Anasept® also inhibits the growth of bacteria such as Staphylococcus aureus, Pseudomonas aeruginosa, Escherichia coli, Proteus mirabilis, Serratia marcescens, Acinetobacter baumannii, Clostridium difficile and antibiotic resistant strains such as Methicillin resistant Staphylococcus aureus (MRSA), Vancomycin resistant Enterococcus faecalis (VRE), Carbapenem resistant E.coli (CRE) that are commonly found in wound bed as well as fungi such as Aspergillus niger, Candida albicans and Candida auris.
Recalls
| Date | Firm | Reason |
|---|---|---|
| 2024-03-19 | Medtronic Perfusion Systems | Potential for unsealed sterile packing. |
| 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 |
| 2019-08-16 | IrriMAX Corporation | Potential defect in the sterile pouch seal, which may result in a lack of sterility assurance. |
| 2019-01-24 | Maquet Cardiovascular, LLC | Potential lack of carbon dioxide (CO2) flow that may result in a procedural delay during off-pump coronary artery bypass (OPCAB). |
| 2017-11-09 | Stryker Instruments Div. of Stryker Corporation | Lack of sterility assurance as bioburden levels were found to be higher than internal acceptable rates. |
| 2017-09-05 | Medex Cardio-Pulmonary Inc., d.b.a. Smiths Medical Company | Lack of sterility assurance: leaking containers which could lead to exposure to infectious agents. |
| 2015-05-08 | Stryker Instruments Div. of Stryker Corporation | Potential sterility breach in the packaging. |
| 2015-02-11 | EXP Pharmaceutical Services Corp | EXP did not register as a medical device establishment, list the devices being recalled, or establish its own quality system and instead relied on the fact that its vendors were re |
| 2010-10-04 | Stryker Instruments Division of Stryker Corporation | There is potential for a breach in sterility in the blister packaging. This can lead to the use of non-sterile product which, if contaminated, could lead to a patient infection. |
| 2010-10-04 | Stryker Instruments Division of Stryker Corporation | There is potential for a breach in sterility in the blister packaging. This can lead to the use of non-sterile product which, if contaminated, could lead to a patient infection. |
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