Arrow International Recalls Spring-Wire Guide Introducer Catheter Assemblies
Arrow International Inc is recalling 416,055 Spring-Wire Guide Introducer Catheter Assemblies because the packaging may be unsealed, potentially compromising product sterility.
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 product is a medical device with Class II classification. The hazard involves compromised sterility due to unsealed packaging, which presents a risk of harm (infection) where injury has not yet been reported. This aligns with the 'risk-of-harm products where injury has not yet been reported' criterion for a High severity score.
Plain-English summary
Arrow International Inc has initiated a recall of its Spring-Wire Guide Introducer Catheter Assembly (Product Code: CN-04018). The company is recalling a total of 416,055 units due to potential packaging defects. Specifically, the product sterility may be compromised because some units were shipped with unsealed packaging.
The recall affects specific lot numbers: 13F17B0039, 13F17C0181, 13F17D0226, 13F17E0065, 13F17E0724, 13F17F0651, 13F17G0531, 13F17H0377, 13F17J0273, 13F17L0216, and 13F17L0218. These products were distributed nationwide in the United States as well as in Australia, Austria, Belgium, Canada, the Czech Republic, Denmark, Ecuador, France, Germany, Greece, Hong Kong, Indonesia, Ireland, Italy, Japan, Korea, the Netherlands, New Zealand, Panama, the Philippines, Poland, Puerto Rico, Romania, Saudi Arabia, Singapore, Slovenia, South Africa, Spain, Sweden, Switzerland, Thailand, and Trinidad and Tobago.
Consumers or healthcare providers who possess these catheter assemblies should stop using them immediately. The unsealed packaging poses a risk that the sterile field of the medical device has been breached. For more information, refer to the FDA recall notice at https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=Z-2011-2018.
The recalled product
- Product
- Spring-Wire Guide Introducer Catheter Assembly; Product Code: CN-04018
- Manufacturer
- Arrow International Inc
- 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
- 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 · sterility compromise
See all →- SevereSpectra Medical Devices Recalls Sodium Chloride Injection Ampules Due to Sterility Concerns
FDA (Devices) · 2026-08-19
- HighIntramedullary Bone Saw Blade Assembly Recalled Due to Potential Sterile Barrier Damage
FDA (Devices) · 2026-08-12
- ModerateIntramedullary Bone Saw Blade Assembly Recalled Due to Potential Sterile Barrier Damage
FDA (Devices) · 2026-08-12
- HighStryker Recalls Ahto Dual Spike Tube Set Due to Leaking Handpiece
FDA (Devices) · 2026-08-12
- HighIntramedullary Bone Saw Blade Assemblies Recalled Due to Potential Packaging Damage
FDA (Devices) · 2026-08-12