ARROW Pressure Injectable Arrowg+ard Blue Advance recall: Labeling Error
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…
Why was ARROW Pressure Injectable Arrowg+ard Blue Advance 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).
What should I do if I have this product?
Review the official FDA enforcement record for current instructions.
What to do with a recalled product: refunds, receipts, safe disposal and how to report a problem.
Is my product affected?
Compare the item in your hand with every identifier below from the official FDA record. Only products that match the listed product and lot, UPC or model codes are part of this recall.
Which lot codes, UPCs or models are affected?
UDI (01)10801902144284(17)230731(11)220504(10)13F22C0757
- Product
- 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…
- Recalling firm
- ARROW INTERNATIONAL Inc.
- Quantity
- 18 devices
- Distribution
- US Nationwide distribution in the state of Florida.
- Recall date
- October 26, 2022
- Classification
- Class II
- Status
- Terminated
- Agency
- FDA (device)