Arrow International Recalls Two-Lumen Central Venous Catheterization Kits
Arrow International is recalling 416,055 two-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 3/5 (High).
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 involves a medical device where sterility may be compromised, posing a risk of harm (infection) even though no specific injuries or illnesses are reported in the source text. This aligns with the 'High' severity criteria for risk-of-harm products where injury has not yet been reported.
Plain-English summary
Arrow International Inc is recalling 416,055 units of the Two-Lumen Central Venous Catheterization Kit with Blue FlexTip(R), ARROWg+ard Blue PLUS(R) Catheter, Sharps Safety Features and Maximal Barrier Precautions. The recall affects specific lot numbers: 13F17C0063, 13F17F0665, and 13F17H0388.
The recall was initiated because product sterility may be compromised due to unsealed packaging. This defect could potentially allow contamination of the medical device.
The affected products were distributed in the United States and numerous international locations, including Australia, Canada, the United Kingdom, and various countries in Europe, Asia, and the Americas. Healthcare providers and facilities should check their inventory for the specific lot numbers listed and stop using the affected kits.
The recalled product
- Product
- Two-Lumen Central Venous Catheterization Kit with Blue FlexTip(R), ARROWg+ard Blue PLUS(R) Catheter, Sharps Safety Features and Maximal Barrier Precautions; Product Code: ASK-42802-DMC
- 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: 13F17C0063 13F17F0665 13F17H0388
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
- ModerateArrow Central Venous Catheter Kits Recalled for Missing Clinical Documentation
FDA (Devices) · 2018-03-28
- HighArrow International Recalls Central Venous Access Kits Due to Sterility Concerns
FDA (Devices) · 2018-04-18
- HighArrow Recalls Single-Lumen Central Venous Catheter Kits Due to Packaging Seal Issues
FDA (Devices) · 2017-06-21