Arrow Select Kit Ultrasound Catheters Recalled for Packaging Molding Abnormality
Arrow International Inc. is recalling 6,121 units of Arrow Select Kit ultrasound catheters due to a component molding abnormality in the packaging.
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 identifies a packaging molding abnormality without reporting any illnesses or injuries, fitting the criteria for a moderate severity precautionary recall.
Plain-English summary
Arrow International Inc. is recalling 6,121 units of Arrow Select Kit (ASK) ultrasound intravascular catheters. The recall was initiated due to a notification from a supplier regarding a component molding abnormality used to package these products. The VPS Stylet and Console are indicated for guidance and tip positioning for central venous catheters.
The affected products were distributed in the United States to the states of North Carolina, Ohio, Florida, and Maryland. Specific lot numbers are listed in the recall documentation.
Consumers and healthcare facilities should stop using the affected products and contact Arrow International Inc. for further instructions or a replacement.
The recalled product
- Product
- Cather, Ultrasound, Intravascular The VPS Stylet and Console are indicated for guidance and tip positioning for central venous catheters.
- Manufacturer
- Arrow International Inc
- Category
- Medical Device — Catheters
- Hazard
- Affected units
- 6,121
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 (20)
- Lot/Batch Numbers: 23F15L0662
- 23F15J0260
- 23F15K0983
- 23F15G0159
- 23F15J1102
- 23F15J0259 23F15C1225
- 23S15G0973
- 23F15H1033
- 23F15F0358
- 23F15K0345
- 23F15D1514 23F15C1226
- 23F15H0919
- 23F15E1091
- 23F15H0014
- 23F15D0241
- 23F15J0533 23F15E1094
- 23F15H0020
- 23F15H0740
- 23F15K1009
- 23F15J0431
Distribution
Part of a larger recall action
This product is one of 4 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 4 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 · packaging defect
See all →- HighEmbosphere Microspheres Recalled Due to Packaging Sterility Concerns
FDA (Devices) · 2026-10-07
- ModerateAmneal Recalls Estradiol Gel Packets Due to Empty or Partially Full Containers
FDA (Drugs) · 2026-10-07
- HighCardinal Health Recalls Presource Convenience Kits Due to Seal Defects
FDA (Devices) · 2026-09-30
- ModerateAVID Medical Recalls Halyard IV Start Kits Due to Packaging Seal Issues
FDA (Devices) · 2026-09-30
- HighCardinal Health Recalls Presource Convenience Kits Due to Potential Seal Defects
FDA (Devices) · 2026-09-30
Similar recalls
- ModerateArrow International Recalls Central Venous Catheter Kits Due to Packaging Issues
FDA (Devices) · 2018-06-06
- HighArrow International Recalls Central Venous Catheter Kits Due to Packaging Defect
FDA (Devices) · 2018-06-06
- HighArrow Central Venous Catheter Kits Recalled for Packaging Defect
FDA (Devices) · 2018-06-06
- ModerateArrow Central Venous Catheter Kits Recalled for Unsealed Packaging
FDA (Devices) · 2018-06-06
- HighArrow Central Venous Catheter Kits Recalled for Packaging Sterility Concerns
FDA (Devices) · 2018-06-06
- HighArrow Central Venous Catheterization Kit Recalled for Unsealed Packaging
FDA (Devices) · 2018-06-06