FDA-Device2025-12-17Class II

Hemodialysis System, Surdial DX REF: MC+SDX01 Rx Only

Nipro Medical Corporation
Hazard

Screw may loosen or fallout of Hemodialysis system

Sold states
US Nationwide distribution in the states of AL, AR, CA, FL, GA, IL, IA, MI, MN, MS, NJ, NY, NC, ND, OH, OR, PA, SC, SD, TX, WV, WC.
Affected count
N/A
Manufactured in
3150 NW 107th Ave, N/A, Doral, FL, United States
Products
Hemodialysis System, Surdial DX REF: MC+SDX01 Rx Only

Official notice

https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-0912-2026

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