ARROW INTERNATIONAL Inc.: 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 in

Hazard

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).

Details from the source

Reason for recall: 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). Distribution: US Nationwide distribution in the state of Florida. Quantity: 18 devices Lot/code info: UDI (01)10801902144284(17)230731(11)220504(10)13F22C0757

UPC codes

10801902144284

Source

Official record: FDA (Device enforcement) ↗

Republished from the official source above; details can change — the source record controls.