Arrow International Recalls PICC Catheters Due to Incorrect Expiration Date
Arrow International is recalling 350 units of Arrowg+ard Blue Advance PICC catheters because the product labels display an incorrect expiration date.
The agency’s classification
FDA (Devices): Class II
Class II is a situation in which use of or exposure to a violative product may cause temporary or medically reversible adverse health consequences, or where the probability of serious adverse health consequences is remote.
This is the agency’s own classification, taken from its notice. The severity score below is our assessment, not the agency’s. How recall classes work
What this means for you
Our assessment, not the agency’s: severity 2/5 (Moderate).
Minor labeling or packaging issue, or a voluntary precautionary recall. Risk of harm is low but real — follow the manufacturer's instructions.
Our severity reasoning: The recall is classified as FDA Class II and involves a labeling error (incorrect expiration date) without reported injuries or illnesses, fitting the criteria for a moderate severity voluntary precautionary recall.
Plain-English summary
Arrow International Inc is voluntarily recalling 350 units of Arrowg+ard Blue Advance PICC pre loaded with Arrow VPS Precision Stylet. The recall is being conducted because the product labels contain an incorrect expiration date. The affected products are identified by batch codes 23F17B0463 and 23F18E0251.
The recall is classified as Class II by the U.S. Food and Drug Administration. The products were distributed nationwide and to foreign locations. No specific illnesses or injuries have been reported in the source text.
Healthcare facilities and consumers should stop using the affected products and contact Arrow International Inc for further instructions or a return.
The recalled product
- Product
- Arrowg+ard Blue Advance PICC pre loaded with Arrow¿ VPS" Precision Stylet Product Code: CDC 45063 HPK1A
- Manufacturer
- Arrow International Inc
- Category
- Medical Device — Catheters
- Hazard
- Affected units
- 350
Is your product affected?
Check your packaging against the codes below. If any of them match, the product is part of this recall.
Lot numbers (2)
- Batch Code :23F17B0463
- 23F18E0251
Distribution
Distributed nationwide across the United States.
Part of a larger recall action
This product is one of 36 recalled by Arrow International Inc under a single FDA (Devices) recall action. The agency files each product separately, so the size of the action is not visible from this page alone.
See all 36 products in this recall →Related recalls
Same manufacturer · Arrow International Inc
See all →- HighArrow Arterial Kits Recalled Due to Open Packaging Seals
FDA (Devices) · 2024-10-02
- SevereIntra-Aortic Balloon Catheter Kit Recalled for Inflation and Structural Defects
FDA (Devices) · 2024-06-12
- SevereArrow UltraFlex Intra-Aortic Balloon Catheter Kit Recalled for Device Malfunction
FDA (Devices) · 2024-06-12
- SevereArrow Ultra 8 Intra-Aortic Balloon Catheter Kit Recalled for Inflation Defect
FDA (Devices) · 2024-06-12
- SevereARROW QuickFlash Radial Artery Catheters Recalled for Defective Component
FDA (Devices) · 2024-03-27
Same hazard · mis labeling
See all →- SevereWhite Vein Advanced Alkaloids Chewable Tablets Recall for Excess Active Ingredient
FDA (Food) · 2026-10-14
- SevereBetter Bakehouse Recalls Donutful Chocolate Dipped Vanilla Cake Donuts for Undeclared Milk
FDA (Food) · 2026-10-14
- HighFreshPoint Recalls Cranberry Chicken Salad Wedges for Undeclared Egg Allergen
FDA (Food) · 2026-10-14
- HighJ K Patisserie & Bakery LLC Recalls Croissants for Undeclared Egg
FDA (Food) · 2026-10-14
- LowMindray ePM Series Patient Monitor Manuals Recalled for Alarm Clarification
FDA (Devices) · 2026-10-14
Similar recalls
- SevereArrow PICC Catheters Recalled for Incorrect Product Label Information
FDA (Devices) · 2023-10-11
- SevereFDA Recalls Arrow PICC Catheters with Incorrect Product Code Labels
FDA (Devices) · 2023-10-11
- ModerateArrow International Recalls PICC Catheter Kits Due to Incorrect Components
FDA (Devices) · 2018-02-21
- ModerateArrow International Recalls PICC Sets with Incorrect Expiration Dates
FDA (Devices) · 2020-02-26
- ModerateArrow Pressure Injectable PICC Catheter Recall Due to Incorrect Length
FDA (Devices) · 2014-04-30
- LowArrow ErgoPack PICC catheter kits recalled for incorrect product labeling
FDA (Devices) · 2023-09-27