HydroFinity Hydrophilic guidewire recall
HydroFinity Hydrophilic guidewire; Nitinol Guidewire with Hydrophilic Coating, Sterile. 0.035 OD, Standard Shaft, Angled Tip, 150 CM Length…
Why was HydroFinity Hydrophilic guidewire recalled?
Reports of outer polymer jacket to the core wire being damaged during use on the HydroFinity Guidewire.
What should I do if I have this product?
Review the official FDA enforcement record for current instructions.
What to do with a recalled product: refunds, receipts, safe disposal and how to report a problem.
Is my product affected?
Compare the item in your hand with every identifier below from the official FDA record. Only products that match the listed product and lot, UPC or model codes are part of this recall.
Which lot codes, UPCs or models are affected?
Model HPRA35150 - all lots.
- Product
- HydroFinity Hydrophilic guidewire; Nitinol Guidewire with Hydrophilic Coating, Sterile. 0.035 OD, Standard Shaft, Angled Tip, 150 CM Length…
- Recalling firm
- Nitinol Devices and Components, Inc.
- Quantity
- 8485 in US, 9595 - ROW - total, all models
- Distribution
- Worldwide Distribution - USA (nationwide) and Internationally to Italy, France, Norway, Sweden, Germany, Belgium, United Kingdom and Canada.
- Recall date
- July 2, 2014
- Classification
- Class I
- Status
- Terminated
- Agency
- FDA (device)