ARROW INTERNATIONAL Inc.: Medical Device Recall in 2022 - (Recall #: Z-0102-2023)
See the recall detail below. You can also see other recalls from the same firm in 2022.
ARROW Pressure Injectable Arrowg+ard Blue Advance Two-Lumen Midline Kit, 5.5 Fr, 15 cm, .018 Inch dia., REF ASK-41552-JHVA1. For peripheral access to the venous system for intravenous therapy, blood sampling, infusion, and pressure injection of contrast media.
Class II
Mislabeling: the corrugate label, lidstock, banner card, and peel sticker accompanying the affected product incorrectly displays a double lumen 5.5 French catheter (and related priming volumes and kit contents for product code ASK-41552-JHVA1), instead of the packaged single-lumen 4.5 French catheter (and related priming volumes and kit contents for product code ASK-41541-JHVA1).
UDI (01)10801902144284(17)230731(11)220504(10)13F22C0757
US Nationwide distribution in the state of Florida.
Voluntary: Firm initiated