Arrow International Recalls Hemodialysis Catheterization Kits with Incorrect Guide
Arrow International Inc is recalling specific lots of ARROWg+ard Blue Two Lumen Hemodialysis Catheterization Kits because they may contain the incorrect Springwire Guide.
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 injuries, illnesses, or deaths. The hazard is a component mismatch (incorrect Springwire Guide) without reported adverse health consequences, fitting the criteria for a moderate severity score.
Plain-English summary
Arrow International Inc is recalling 5,926 units of ARROWg+ard Blue Two Lumen Hemodialysis Catheterization Kits for High Volume Infusions. The affected product codes are AK-22142-CDC, AK-22142-F, AK-25142-CDC, and AK-25142-F, with expiration dates ranging from February 2018 to November 2018.
The recall was initiated because these finished good kits may contain the incorrect Springwire Guide (SWG). The affected lots are distributed nationwide in the United States.
Healthcare facilities and consumers should stop using these specific kits and contact Arrow International Inc for further instructions or a replacement.
The recalled product
- Product
- ARROWg+ard Blue Two Lumen Hemodialysis Catheterization Kit for High Volume Infusions; Product Codes: AK-22142-CDC, AK-22142-F, AK-25142-CDC, AK-25142-F; Exp. Dates Feb 2018 - Nov 2018
- Manufacturer
- Arrow International Inc
- Hazard
- Affected units
- 5,926
Distribution
Distributed nationwide across the United States.
Part of a larger recall action
This product is one of 12 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 12 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 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
- SevereARROW QuickFlash Radial Artery Catheters Recalled for Defective Component
FDA (Devices) · 2024-03-27
Same hazard · incorrect component
See all →- ModerateDeRoyal Myocardial Probe Recall Due to Incorrect Needle Length
FDA (Devices) · 2026-09-30
- HighWaldemar Link Recalls Endo-Model Tibial Plateau Replacement Sets
FDA (Devices) · 2026-08-19
- HighTMJ Bilateral Implants with Incorrect Patient-Specific Components Recalled
FDA (Devices) · 2026-07-01
- HighDisposable 5 Lead Cable System May Contain Non-Approved ECG Leads
FDA (Devices) · 2024-08-28
- HighReverse Shoulder Prosthesis Screws May Have Incorrect Size
FDA (Devices) · 2023-10-18
Similar recalls
- HighArrow Hemodialysis Catheter Kits Recalled for Sterility Concerns
FDA (Devices) · 2018-04-18
- HighArrow International Recalls Hemodialysis Catheter Kits Due to Packaging Seal Issues
FDA (Devices) · 2017-06-21
- ModerateArrow International Recalls Hemodialysis Catheterization Kits
FDA (Devices) · 2017-06-14
- HighArrow International Recalls Two-Lumen Hemodialysis Catheterization Kits
FDA (Devices) · 2017-06-14
- HighArrow International Recalls Central Venous Catheter Kits Due to Sterility Risk
FDA (Devices) · 2018-06-06
- HighArrow International Recalls Central Venous Catheter Kits Due to Sterility Concerns
FDA (Devices) · 2018-06-06