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Intuitive Surgical, Inc. recalls EndoWrist Suction Irrigator, Single Use Instrument. Part Number: 480299-04. An accessory to the EndoWrist Surgical S
Recalled November 6, 2019 · FDA recall Z-0249-2020 · Intuitive Surgical
Hazard
The firm has identified the potential for a silicone particle to be generated within the Suction Irrigator device. If generated, a particle may be introduced into the patient with irrigation. · FDA Class II
Units
3108 units (518 boxes of 6 units)
Sold at
Worldwide distribution. US nationwide, Australia, Italy, Switzerland, and United Kingdom.
Description
The firm has identified the potential for a silicone particle to be generated within the Suction Irrigator device. If generated, a particle may be introduced into the patient with irrigation.
Product
EndoWrist Suction Irrigator, Single Use Instrument. Part Number: 480299-04. An accessory to the EndoWrist Surgical System, used in endoscopic surgery.
Manufacturer(s)
Intuitive Surgical, Inc.
Source: U.S. Food and Drug Administration. Official recall notice on fda.gov →