HydroPICC 5Fr Dual Lumen Maximal Barrier Kit, Product Model Number 80002004
Specific lots of the Dual Lumen HydroPICC Kits were provided with the incorrect revision of the Instructions For Use (IFU) which do not include the following warnings statement: HydroPICC Dual Lumen Catheter is for adult use only. There is a potential risk to health should the HydroPICC Dual Lumen Catheter be used in an inadequately sized vessel. There have been no reported adverse events to date.
US Nationwide distribution in the states of IL, TX.
https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-0115-2024