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Intuitive Surgical, Inc. recalls ION Reprocessing Accessories Kit, IF1000 (Part Number: 490024-03) UDI:00886874119129. The kit includes an ION Catheter R
Recalled September 16, 2020 · FDA recall Z-2950-2020 · Intuitive Surgical
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. · FDA Class II
Units
27 units
Sold at
U.S.: California, Colorado, Florida, Illinois, Massachusetts, New Jersey, New York, North Carolina, Ohio, Pennsylvania, Texas, and Virginia. No foreign consignees.
Description
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.
Product
ION Reprocessing Accessories Kit, IF1000 (Part Number: 490024-03) UDI:00886874119129. The kit includes an ION Catheter Reprocessing Cover (Part Number: 490114-02).
Manufacturer(s)
Intuitive Surgical, Inc.
Source: U.S. Food and Drug Administration. Official recall notice on fda.gov →