FDA-Device2020-09-16Class II
Ion Catheter Reprocessing Cover, IF1000 (Part Number:490114-02) UDI:00886874116845.
Intuitive Surgical, Inc.
Hazard
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.
Sold states
U.S.: California, Colorado, Florida, Illinois, Massachusetts, New Jersey, New York, North Carolina, Ohio, Pennsylvania, Texas, and Virginia. No foreign consignees.
Affected count
67 units
Manufactured in
1266 Kifer Rd Bldg 101, Sunnyvale, CA, United States
Products
Ion Catheter Reprocessing Cover, IF1000 (Part Number:490114-02) UDI:00886874116845.
Official notice
https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-2949-2020Don't want to check this manually?
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