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Natus Medical Incorporated recalls EDS 3 CSF External Drainage System, REF: NT821731C, STERILEEO, Rx only
Recalled January 10, 2024 · FDA recall Z-0635-2024 · Natus Medical Incorporated
Hazard
Sterility assurance cannot be guaranteed for external drainage systems due to incomplete bioburden testing. · FDA Class II
Units
3,336 units
Sold at
US Nationwide distribution including in the states of AL, AR, AZ, CA, CO, CT, DC, FL, GA, IL, IN, KS, KY, LA, MA, MD, ME, MI, MO, MS, MT, NC, ND, NE, NH, NJ, NM, NY, OH, OK, OR, PA, RI, SC, TN, TX, UT, VA, WA, WI, WV.
Description
Sterility assurance cannot be guaranteed for external drainage systems due to incomplete bioburden testing.
Product
EDS 3 CSF External Drainage System, REF: NT821731C, STERILEEO, Rx only
Manufacturer(s)
Natus Medical Incorporated
Source: U.S. Food and Drug Administration. Official recall notice on fda.gov →