Arrow International Recalls Central Venous Catheter Kits Due to Packaging Issues
Arrow International is recalling 416,055 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 hazard involves a packaging defect that may compromise sterility. As no specific injuries or illnesses are reported in the source text, it falls under the moderate category for potential risk without confirmed harm.
Plain-English summary
Arrow International Inc is recalling 416,055 units of Pressure Injectable Multi-Lumen Central Venous Catheterization Kits with Blue FlexTip, ARROWg+ard Blue PLUS Catheter, Sharps Safety Features and Maximal Barrier Precautions. The recall affects specific product codes ASK-45703-LDP1, ASK-45703-PBHS, and ASK-45703-PHMC, distributed in the United States and numerous international locations.
The recall was initiated because product sterility may be compromised due to unsealed packaging. This defect poses a risk of infection if the non-sterile product is used in a clinical setting.
Healthcare providers and consumers should stop using the affected products immediately. Users should check their inventory for the specific lot numbers listed in the recall notice and contact Arrow International Inc for instructions on returning the products.
The recalled product
- Product
- Pressure Injectable Multi-Lumen Central Venous Catheterization Kit with Blue FlexTip¿, ARROWg+ard Blue PLUS¿ Catheter, Sharps Safety Features and Maximal Barrier Precautions; Product Codes: ASK-45703-LDP1, ASK-45703-PBHS, ASK-45703-PHMC
- Manufacturer
- Arrow International Inc
- Category
- Medical Device — Catheters
- Affected units
- 416,055
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 ARROWg+ard Blue CVC Kits
FDA (Devices) · 2018-04-18
- HighArrow International Recalls Certain Lots of Central Venous Catheter Kits
FDA (Devices) · 2018-04-18
- ModerateArrow Central Venous Catheter Kits Recalled for Missing Clinical Documentation
FDA (Devices) · 2018-03-28