Nipro AquaLiner Hydrophilic Guidewire Recalled for Insufficient Lubricity
Nipro Medical Corporation is recalling AquaLiner Hydrophilic Guidewires because insufficient lubricity causes them to get stuck in the housing and become nonfunctional.
What this means for you
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. The hazard is a functional defect (nonfunctional device) rather than a direct physical injury or contamination, and no injuries or illnesses are reported in the source text.
Plain-English summary
Nipro Medical Corporation, based in Miami, Florida, is recalling 400 units of the AquaLiner Hydrophilic Guidewire 0.035" X 260cm, Angle/ Regular. The guidewires are designed for use in angiographic procedures to introduce and position catheters and interventional devices within the vasculature.
The recall was initiated because the wires contain insufficient lubricity. This defect causes the wires to get stuck in the housing, rendering them nonfunctional. The affected units are identified by Item Code AL+60000303 and Lot numbers 11I27 and 12B13.
The products were distributed worldwide, specifically in the state of New York and the countries of Spain, Germany, Argentina, Panama, Mexico, Chile, Colombia, Ecuador, Peru, and Brazil. Healthcare providers and facilities should stop using the affected guidewires and contact the manufacturer for further instructions.
The recalled product
- Product
- AquaLiner Hydrophilic Guidewire 0.035" X 260cm, Angle/ Regular. AquaLiner Hydrophilic Guidewire is designed for use in angiographic procedures to introduce/ position catheters and interventional devices within the vasculature.
- Manufacturer
- Nipro Medical Corporation
- Hazard
- Affected units
- 400
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 (2)
- Item Code: AL+60000303 Lot #: 11I27
- 12B13
Distribution
Distributed in 1 state:
Part of a larger recall action
This product is one of 5 recalled by Nipro Medical Corporation 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.
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