Arrow International Recalls Femoral Arterial Line Catheterization Kits
Arrow International is recalling specific femoral arterial line catheterization kits due to reports of safety cover disengagement and needlestick injuries associated with packaged BD Eclipse Needles.
What this means for you
Real risk of harm even if no illness or injury has been reported yet. Stop using the product and follow the agency's guidance.
Our severity reasoning: The recall is classified as FDA Class II and involves reported needlestick injuries, which are significant physical hazards, but does not meet the criteria for Class I (death/serious injury) or Severe (hospitalization reports).
Plain-English summary
Arrow International Inc. has initiated a recall of the Femoral Arterial Line Catheterization Kit, identified by material number ASK-04018-HCA. The recall is driven by reports of safety cover disengagement and needlestick injuries involving the BD Eclipse Needle, which is packaged with certain Arrow products.
The affected devices are distributed nationwide. The Arrow Arterial Catheterization device is designed to permit access to the peripheral arterial circulation or other small vessels. The recall specifically addresses the safety mechanism of the needle component included in the kit.
Healthcare facilities and consumers should stop using the affected kits and contact Arrow International for further instructions or replacement units. This recall is classified as Class II by the FDA, indicating a reasonable probability that use of the product could cause temporary or medically reversible health consequences.
The recalled product
- Product
- Femoral Arterial Line Catheterization Kit The Arrow¿ Arterial Catheterization device permits access to the peripheral arterial circulation or to other small vessels
- Manufacturer
- Arrow International Inc
- Category
- Medical Device — Catheters
- Affected units
- 43,394
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)
- Material number ASK-04018-HCA
Distribution
Distributed nationwide across the United States.
Part of a larger recall action
This product is one of 56 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 56 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
- 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
- SevereIntra-Aortic Balloon Catheter Kit Recalled for Inflation and Structural Defects
FDA (Devices) · 2024-06-12
- SevereARROW QuickFlash Radial Artery Catheters Recalled for Defective Component
FDA (Devices) · 2024-03-27
Same hazard · needlestick injury
See all →- HighMedline IV Catheter Kits Recalled Over Needle Retraction Issue
FDA (Devices) · 2025-07-09
- HighBD Insyte Autoguard IV Catheter Needles May Fail to Retract Properly
FDA (Devices) · 2023-12-06
- HighSafety Blood Collection Needles Recalled Due to Safety Mechanism Activation Difficulty
FDA (Devices) · 2021-11-17
- HighBD Nexiva IV Catheter Recall Due to Needle Shield Failure
FDA (Devices) · 2018-11-14
- SevereArrow International Recalls Access Kits Due to Needlestick Injury Risk
FDA (Devices) · 2017-06-14