Arrow International Recalls Multi-Lumen Central Venous Catheterization Kits
Arrow International is recalling 416,055 Multi-Lumen Central Venous Catheterization Kits because unsealed packaging may compromise product sterility.
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 the source text does not report any illnesses, injuries, or hospitalizations, fitting the criteria for a moderate severity precautionary recall.
Plain-English summary
Arrow International Inc is recalling 416,055 units of the Multi-Lumen Central Venous Catheterization Kit with Blue FlexTip(R), ARROWg+ard Blue PLUS(R) Catheter and Sharps Safety Features. The recall is being conducted because product sterility may be compromised due to unsealed packaging.
The affected product is identified by product code ASK-45703-AEH and specific lot numbers: 13F17E0712, 13F17H0264, 13F17K0086, 13F17K0547, and 13F17L0647. The products were distributed in the United States and numerous international locations, including Australia, Canada, and the United Kingdom.
Healthcare facilities and consumers should check their inventory for the specific product code and lot numbers listed above. If the product is found, it should be removed from use and returned to the manufacturer or disposed of according to local regulations.
The recalled product
- Product
- Multi-Lumen Central Venous Catheterization Kit with Blue FlexTip(R), ARROWg+ard Blue PLUS(R) Catheter and Sharps Safety Features; Product code: ASK-45703-AEH
- Manufacturer
- Arrow International Inc
- Category
- Medical Device — Catheter
- Affected units
- 416,055
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)
- Lot Numbers: 13F17E0712 13F17H0264 13F17K0086 13F17K0547 13F17L0647
Distribution
Part of a larger recall action
This product is one of 76 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 76 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 · sterility compromise
See all →- ModerateAVID Medical Recalls Halyard IV Start Kits Due to Packaging Seal Issues
FDA (Devices) · 2026-09-30
- HighMedline Recalls Cataract Convenience Kits Due to Open Sterile Seals
FDA (Devices) · 2026-09-23
- HighMedline Myringotomy Kits Recalled for Potential Sterility Compromise
FDA (Devices) · 2026-09-23
- HighMedline Anesthesia Pain Kits Recalled for Potential Sterility Compromise
FDA (Devices) · 2026-09-23
- HighMaquet Percutaneous Insertion Kit Recalled for Sterile Barrier Integrity Issues
FDA (Devices) · 2026-09-23
Similar recalls
- ModerateArrow Recalls Central Venous Catheter Kits Due to Sterility Concerns
FDA (Devices) · 2017-06-21
- ModerateArrow International Recalls Central Venous Catheter Kits Due to Packaging Seal Issues
FDA (Devices) · 2017-06-21
- HighArrow International Recalls Certain Central Venous Catheterization Kits
FDA (Devices) · 2018-04-18
- HighArrow International Recalls Certain Lots of Central Venous Catheter Kits
FDA (Devices) · 2018-04-18
- ModerateArrow International Recalls Central Venous Catheter Kits with Incorrect Guide
FDA (Devices) · 2018-02-28
- HighArrow International Recalls Certain Lots of ARROWg+ard Blue CVC Kits
FDA (Devices) · 2018-04-18