Class II
Medical Device Recall: EDS 3 CSF External Drainage System, REF: NT821731C, STERILEEO, Rx only
Natus Medical Incorporated · November 28, 2023
Reason for Recall
Sterility assurance cannot be guaranteed for external drainage systems due to incomplete bioburden testing.
Distribution
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.
States Affected
NATIONWIDE
Quantity Affected
3,336 units
Source: FDA (openFDA Device Enforcement)
Recall number: Z-0635-2024
Status: ongoing
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