Z-2949-2020 Class II Ongoing
FDA device recall Z-2949-2020 was initiated by Intuitive Surgical, Inc. on June 10, 2020 and is designated Class II. Reason for recall: 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 cl… The recall status is ongoing. Affected quantity: 67 units.
Recall Details
- Product Type
- Devices
- Report Date
- September 16, 2020
- Initiation Date
- June 10, 2020
- Termination Date
- N/A
- Voluntary/Mandated
- Voluntary: Firm initiated
- Product Quantity
- 67 units
Product Description
Ion Catheter Reprocessing Cover, IF1000 (Part Number:490114-02) UDI:00886874116845.
Reason for Recall
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.
Distribution Pattern
U.S.: California, Colorado, Florida, Illinois, Massachusetts, New Jersey, New York, North Carolina, Ohio, Pennsylvania, Texas, and Virginia. No foreign consignees.
Code Information
All lots.