Device product
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.
Z-1552-2021
Product summary
- Event
- Event 87656
- Status
- Terminated
- Classification
- Class II
- Quantity
- 287 units
- Official record key
device-enforcement:Z-1552-2021
Official wording
Reason: Catheters may experience difficulty in flushing, infusion, and/or aspiration, and septum dislodgements.
Code information: Code: REEV2356, REEX1383, REEX3996
Distribution pattern: 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.
Derived failure modes
-
Unknown
Catheters may experience difficulty in flushing, infusion, and/or aspiration, and septum dislodgements.