Swan-Ganz CCO/Sv02/CEDV/VIP Thermodilution Catheters recall
Swan-Ganz CCO/Sv02/CEDV/VIP Thermodilution Catheters model number 744HF75. Flow-directed pulmonary artery catheters for monitoring cardiac output…
Why was Swan-Ganz CCO/Sv02/CEDV/VIP Thermodilution Catheters recalled?
The product failed to meet the internal established statistical test requirement for heparin activity.
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 number 59860969.
- Product
- Swan-Ganz CCO/Sv02/CEDV/VIP Thermodilution Catheters model number 744HF75. Flow-directed pulmonary artery catheters for monitoring cardiac output…
- Recalling firm
- Edwards Lifesciences, LLC
- Quantity
- 978
- Distribution
- Worldwide distribution US nationwide, Canada and Europe (IC, BE, IT, GB, FR, DK, CZ, DE, AT, ES, IE, NO, PL)
- Recall date
- June 10, 2015
- Classification
- Class II
- Status
- Terminated
- Agency
- FDA (device)