FDA-Device2024-01-10Class II
EDS 3 CSF External Drainage System, REF: NT821731C, STERILEEO, Rx only
Natus Medical Incorporated
Hazard
Sterility assurance cannot be guaranteed for external drainage systems due to incomplete bioburden testing.
Sold states
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.
Affected count
3,336 units
Manufactured in
5955 Pacific Center Blvd, N/A, San Diego, CA, United States
Products
EDS 3 CSF External Drainage System, REF: NT821731C, STERILEEO, Rx only
Official notice
https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-0635-2024Don't want to check this manually?
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