Z-0102-2023 Class II Terminated
Recall Details
- Product Type
- Devices
- Report Date
- October 26, 2022
- Initiation Date
- September 14, 2022
- Termination Date
- January 19, 2024
- Voluntary/Mandated
- Voluntary: Firm initiated
- Product Quantity
- 18 devices
Product Description
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.
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 Pattern
US Nationwide distribution in the state of Florida.
Code Information
UDI (01)10801902144284(17)230731(11)220504(10)13F22C0757