Reported Oct 26, 2022 · Terminated
ARROW Pressure Injectable Arrowg+ard Blue Advance Two-Lumen Midline Kit, 5.5 Fr, 15 cm, .018 Inch dia., REF…
ARROW INTERNATIONAL Inc.
Moderate riskThis product could cause temporary or reversible health problems — stop using it.What you should do
Stop using the affected lot and contact the recalling firm for the return or refund process. Check the FDA enforcement report for lot-level detail.
Firm contact: ARROW INTERNATIONAL Inc. · 3015 Carrington Mill Blvd · Morrisville, NC · 27560-5437
Is this the product you have?
- 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.
- Lot codes and dates
- UDI (01)10801902144284(17)230731(11)220504(10)13F22C0757
- Amount recalled
- 18 devices
Where it was sold
- Nationwide
- FL
Why it was recalled
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).
This product could cause temporary or reversible health problems — stop using it.
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