Ion Catheter Reprocessing Cover recall
Ion Catheter Reprocessing Cover, IF1000 (Part Number:490114-02) UDI:00886874116845.
Why was Ion Catheter Reprocessing Cover recalled?
One type of the ION Catheter Reprocessing Covers (PN 490114-02) has the potential to become disengaged or incorrectly engaged to the ION Fully Articulating Catheter which can result in retention of cleaning chemical or water during reprocessing; may cause failure of the ION Fully Articulating Catheter or ION System.
What should I do if I have this product?
The recall is ongoing. Follow the firm and FDA 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?
All lots.
- Product
- Ion Catheter Reprocessing Cover, IF1000 (Part Number:490114-02) UDI:00886874116845.
- Recalling firm
- Intuitive Surgical, Inc.
- Quantity
- 67 units
- Distribution
- U.S.: California, Colorado, Florida, Illinois, Massachusetts, New Jersey, New York, North Carolina, Ohio, Pennsylvania, Texas, and Virginia. No foreign consignees.
- Recall date
- September 16, 2020
- Classification
- Class II
- Status
- Ongoing
- Agency
- FDA (device)