Arrow Femoral Arterial Line Catheterization Kit Recalled for Labeling Error
Arrow International Inc. is recalling 50 units of Femoral Arterial Line Catheterization Kits due to shipping carton labeling errors.
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 minor labeling error regarding shipping cartons, which fits the criteria for a moderate severity score.
Plain-English summary
Arrow International Inc. is recalling 50 units of the Femoral Arterial Line Catheterization Kit with Sharps Safety Features (Material ASK-04018-VUH). The recall was initiated because of a labeling error where some shipping cartons labeled as ASK-04018-VUH contained ASK-04020-VUH kits, and some cartons labeled as ASK-04020-VUH contained ASK-04018-VUH kits.
The affected products are identified by lot numbers 23F14M0829 and 23F14M0986. These products were distributed in the United States in the states of Tennessee and Kentucky. The Arrow arterial catheterization device is used to permit access to the peripheral arterial circulation.
Consumers and healthcare facilities should check their inventory for these specific lot numbers and material codes. If the product is found, it should be removed from use and returned to the manufacturer or the supplier from whom it was purchased.
The recalled product
- Product
- Femoral Arterial Line Catheterization Kit with Sharps Safety Features 510K 810675, product code DQX, Device Listing D025180 Material ASK-04018-VUH Product Usage: The Arrow arterial catheterization device permits access to the peripheral arterial circulation.
- Manufacturer
- Arrow International Inc
- Hazard
- Affected units
- 50
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)
- Lot/Batch Numbers: 23F14M0829
- 23F14M0986
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 Ultra 8 Intra-Aortic Balloon Catheter Kit Recalled for Inflation Defect
FDA (Devices) · 2024-06-12
- SevereArrow UltraFlex Intra-Aortic Balloon Catheter Kit Recalled for Device Malfunction
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
- ModerateHalyard Laparoscopy Comprehensive Pack II Recalled for Latex Content
FDA (Devices) · 2026-10-14
Similar recalls
- LowArrow Arterial Line Catheterization Kits Recalled for Shipping Labeling Error
FDA (Devices) · 2016-09-14
- HighArrow Arterial Catheterization Kit Recalled for Potential Sterility Compromise
FDA (Devices) · 2017-06-21
- ModerateArrow Radial Artery Catheterization Kits Recalled for Shipping Labeling Error
FDA (Devices) · 2016-09-14
- 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
- ModerateArrow Arterial Catherization Kit Recalled for Incorrect MR Labeling
FDA (Devices) · 2020-01-29