FDA-Device2020-06-10Class II

EQUISTREAM¿ XK Long-Term Hemodialysis Catheter. REF/UDI:5913230/:(01)00801741013843; 16F

Bard Peripheral Vascular Inc
Hazard

Incorrect Peel-Apart Introducer Sheath in Kit.

Sold states
67 US Consignees. US - AL, AR, AZ, CA, FL, GA, IA, ID, IL, KY, LA, MD, MN, MT, NC, NY, OR, PA, TN, TX, VA, WA, WI and WV.
Affected count
215
Manufactured in
1625 W 3rd St Bldg 1, N/A, Tempe, AZ, United States
Products
EQUISTREAM¿ XK Long-Term Hemodialysis Catheter. REF/UDI:5913230/:(01)00801741013843; 16F

Official notice

https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-2208-2020

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