FDA-Device2024-01-10Class II
External Drainage System Collection Bag, REF: NT821732C, 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
2,686 units
Manufactured in
5955 Pacific Center Blvd, N/A, San Diego, CA, United States
Products
External Drainage System Collection Bag, REF: NT821732C, STERILEEO, Rx only
Official notice
https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-0634-2024Don't want to check this manually?
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