Codman NeuroPath Guiding Catheters Recalled for Potential Sterility Compromise
Codman & Shurtleff is recalling NeuroPath 6Fx100 Guiding Catheters because package integrity issues may compromise device sterility. The recall covers 34 units distributed worldwide.
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 involves a medical device where sterility may be compromised, creating a risk of harm (infection) even though no specific injuries or illnesses are reported in the source text, which aligns with the 'High' severity criteria for risk-of-harm products without reported injury.
Plain-English summary
Codman & Shurtleff, Inc. is recalling 34 units of the NeuroPath 6Fx100 Guiding Catheter (Product Code: GCB61000000). The recall is being conducted because the sterility of the device may be compromised due to a lack of package integrity. These catheters are intended for use in the coronary, peripheral, and neurovasculature for the intravascular introduction of interventional and diagnostic devices.
The affected units were distributed nationwide in the United States and internationally to Austria, Belgium, Canada, Chile, Costa Rica, Czech Republic, Denmark, France, Germany, Great Britain/UK, Ireland, Italy, Lithuania, Malaysia, Netherlands, New Zealand, Norway, Poland, Portugal, Singapore, Slovakia, Spain, and Switzerland. The recall includes all unexpired lots.
Healthcare providers and facilities that have received these devices should stop using them and contact Codman & Shurtleff, Inc. for further instructions on how to return or dispose of the product.
The recalled product
- Product
- NEUROPATH 6Fx100 GUIDING CATH MC Product Code: GCB61000000 Intended for use in the coronary, peripheral, and neurovasculature for intravascular introduction of interventional/diagnostic devices
- Manufacturer
- Codman & Shurtleff, Inc.
- Category
- Medical Device — Catheters
- Affected units
- 34
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)
- All unexpired lots
Distribution
Distributed nationwide across the United States.
Part of a larger recall action
This product is one of 24 recalled by Codman & Shurtleff, 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.
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