PlainRecalls
FDA Devices Moderate Class II Terminated

PowerPort duo M.R.I. Implantable Port, with attachable 9.5F Polurethane Open-Ended Dual-Lumen Venous Catheter, REF 1829570, UDI: (01) 00801741027192 - 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.

Reported: May 19, 2021 Initiated: March 25, 2021 #Z-1551-2021

Product Description

PowerPort duo M.R.I. Implantable Port, with attachable 9.5F Polurethane Open-Ended Dual-Lumen Venous Catheter, REF 1829570, UDI: (01) 00801741027192 - 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.

Reason for Recall

Catheters may experience difficulty in flushing, infusion, and/or aspiration, and septum dislodgements.

Details

Units Affected
189 units
Distribution
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.
Location
Tempe, AZ

Frequently Asked Questions

What product was recalled?
PowerPort duo M.R.I. Implantable Port, with attachable 9.5F Polurethane Open-Ended Dual-Lumen Venous Catheter, REF 1829570, UDI: (01) 00801741027192 - 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.. Recalled by Bard Peripheral Vascular Inc. Units affected: 189 units.
Why was this product recalled?
Catheters may experience difficulty in flushing, infusion, and/or aspiration, and septum dislodgements.
Which agency issued this recall?
This recall was issued by the FDA Devices on May 19, 2021. Severity: Moderate. Recall number: Z-1551-2021.