Arrow Arterial Line Catheterization Kits Recalled for Shipping Labeling Error
Arrow International Inc. is recalling 690 Arterial Line Catheterization Kits due to a shipping carton labeling error. The kits were distributed nationwide to five states.
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 1/5 (Low).
Cosmetic or documentation issue. No expected health impact, but the manufacturer is correcting the affected products.
Our severity reasoning: The recall is for a shipping carton labeling error, which falls under the 'packaging-only problems' criterion for a Low severity score.
Plain-English summary
Arrow International Inc. is recalling 690 Arterial Line Catheterization Kits with Sharps Safety Features. These devices permit access to the peripheral arterial circulation or to other small vessels. The recall is due to a shipping carton labeling error.
The affected kits were distributed nationwide to Ohio, Indiana, Tennessee, North Carolina, and Kentucky. The device listing number is D025180.
The source text does not specify specific actions for consumers or healthcare providers beyond the recall notice itself.
The recalled product
- Product
- Arterial Line Catheterization Kit with Sharps Safety Features Permits access to the peripheral arterial circulation or to other small vessels.
- Manufacturer
- Arrow International Inc
- Category
- Medical Device — Catheters
- Hazard
- Affected units
- 690
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 (1)
- Device Listing # D025180
Distribution
Part of a larger recall action
This product is one of 2 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 2 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 →- SevereImperio Distribution Recalls Beef Jerky Produced Without Federal Inspection
USDA FSIS · 2026-10-24
- HighJ K Patisserie Chocolate Chip Cookies Recalled for Undeclared Soy
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
- HighArrow Arterial Catheterization Kit Recalled for Potential Sterility Compromise
FDA (Devices) · 2017-06-21
- ModerateArrow Recalls Femoral Arterial Catheterization Kits Due to Labeling Error
FDA (Devices) · 2016-07-20
- ModerateArrow Femoral Arterial Line Catheterization Kit Recalled for Labeling Error
FDA (Devices) · 2016-07-20
- HighArrow Arterial Line Kit Recalled for Potential Sterility Compromise
FDA (Devices) · 2018-06-06
- HighArrow International Recalls Arterial Catheterization Kits Due to Sterility Concerns
FDA (Devices) · 2018-04-18
- HighArrow Radial Artery Catheterization Kit Recalled for Packaging Defect
FDA (Devices) · 2018-06-06