FDA recall Z-0635-2024

Natus Medical Incorporated · Class II · device

Product

EDS 3 CSF External Drainage System, REF: NT821731C, STERILEEO, Rx only

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.

Key facts

Status
Ongoing
Initiation date
2023-11-28
Report date
2024-01-10
Voluntary/Mandated
Voluntary: Firm initiated
Location
San Diego, CA, United States

Primary source

https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-0635-2024