Edwards Lifesciences Swan Ganz Thermodilution Catheter recall
Edwards Lifesciences Swan Ganz Thermodilution Catheter, REF131F 7J Product Usage: The Swan-Ganz Thermodilution Catheter provides a diagnostic tool for…
Why was Edwards Lifesciences Swan Ganz Thermodilution Catheter recalled?
These Swan Ganz catheters have incorrect lumen assembly, which causes reversal of the lumens. If the lumens are reversed the clinician may note reverse PA and CVP pressure values and waveforms.
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?
Lot Numbers: 61321177, 61227528
- Product
- Edwards Lifesciences Swan Ganz Thermodilution Catheter, REF131F 7J Product Usage: The Swan-Ganz Thermodilution Catheter provides a diagnostic tool for…
- Recalling firm
- Edwards Lifesciences, LLC
- Quantity
- 277 units
- Distribution
- Worldwide Distribution
- Recall date
- February 6, 2019
- Classification
- Class I
- Status
- Terminated
- Agency
- FDA (device)