Cardiac Catheterization Waste Management System recall
Cardiac Catheterization Waste Management System w/1000mL Waste Bag, 2 Fluid Admin Sets Product Usage: For waste managment.
Why was Cardiac Catheterization Waste Management System recalled?
The firm initiated the recall due to a molding defect in a high pressure stopcock where a small percentage of the side ports could become totally occluded.
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?
Part Number 460730418 510(k) K052865 Lot number 2444750
- Product
- Cardiac Catheterization Waste Management System w/1000mL Waste Bag, 2 Fluid Admin Sets Product Usage: For waste managment.
- Recalling firm
- ICU Medical, Inc.
- Quantity
- N/A
- Distribution
- Nationwide distribution
- Recall date
- August 8, 2012
- Classification
- Class II
- Status
- Terminated
- Agency
- FDA (device)