FDA-Device2021-05-19Class II
PowerPort duo M.R.I. Implantable Port, with attachable 9.5F Polurethane Open-Ended Dual-Lumen Venous Catheter, REF 5829502, UDI: (01)00801741027406 - Product Usage: The port system can be used for infusion of medications, I.V. fluids, parenteral nutrition solutions, blood products, and for the withdrawal of blood samples.
Bard Peripheral Vascular Inc
Hazard
Catheters may experience difficulty in flushing, infusion, and/or aspiration, and septum dislodgements.
Sold states
US Nationwide distribution in the states of AL, AR, AZ, CA, CO, CT, FL, GA, HI, IA, ID, IL, IN, KS, KY, LA, MA, MD, ME, MI, MN MO, NC, NE, NH, NJ, NM, NY, OH, OK, OR, PA, SC, TN, TX, UT, VA, WA, WI, WV.
Affected count
287 units
Manufactured in
1625 W 3rd St Bldg 1, Tempe, AZ, United States
Products
PowerPort duo M.R.I. Implantable Port, with attachable 9.5F Polurethane Open-Ended Dual-Lumen Venous Catheter, REF 5829502, UDI: (01)00801741027406 - Product Usage: The port system can be used for infusion of medications, I.V. fluids, parenteral nutrition solutions, blood products, and for the withdrawal of blood samples.
Official notice
https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-1552-2021Don't want to check this manually?
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