Arrow Two-Lumen Central Venous Catheter Set Recalled for Labeling Error
Arrow International Inc is recalling 45 units of Two-Lumen Central Venous Catheterization Sets due to incorrect priming volume labeling on the lidstock.
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 due to a labeling error regarding priming volume. This fits the rubric for 'Minor labeling errors' or 'voluntary precautionary recalls' where the hazard is administrative rather than a direct physical defect causing injury.
Plain-English summary
Arrow International Inc is recalling 45 units of Arrow Two-Lumen Central Venous Catheterization Sets with Blue FlexTip Catheter (Product Code: CD-10802). The recall was initiated because the product lidstock contains a labeling error stating the incorrect priming volume. The priming volumes printed on the extension lines are correct.
The affected units were distributed in Florida and North Carolina. Specific lot numbers for the US distribution include 71F15J1055, 71F15K0223, 71F15D1461, and 71F18A1856. Additional worldwide lot numbers are also listed in the official recall record.
Healthcare providers and consumers should check their inventory for these specific lot numbers. If the product is found, it should be returned to the supplier or the manufacturer for replacement or refund. The FDA has classified this as a Class II recall, indicating that use of the product may cause temporary or medically reversible health consequences.
The recalled product
- Product
- Arrow¿ Two-Lumen Central Venous Catheterization Set with Blue FlexTip¿ Catheter Product Code: CD-10802 GTN: 00801902015396
- Manufacturer
- Arrow International Inc
- Category
- Medical Device — Catheters
- Hazard
- Affected units
- 45
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
- ModerateArrow Pediatric Central Venous Catheter Kit Recalled for Labeling Error
FDA (Devices) · 2019-10-16
- ModerateArrow Pediatric Central Venous Catheter Recalled for Incorrect Labeling
FDA (Devices) · 2019-01-23
- ModerateArrow International Recalls Two-Lumen CVC Kits Due to Labeling Error
FDA (Devices) · 2013-08-21
- SevereArrow Central Venous Catheter Recall for Labeling Inconsistency
FDA (Devices) · 2012-07-04
- SevereArrow Central Venous Catheter Recalled for Incorrect Lidstock Labeling
FDA (Devices) · 2023-10-11
- HighArrow International Recalls Two-Lumen Central Venous Catheterization Kits
FDA (Devices) · 2018-06-06