Reported Nov 6, 2019 · Ongoing
EndoWrist Suction Irrigator, Single Use Instrument. Part Number: 480299-04. An accessory to the EndoWrist Surgical…
Intuitive Surgical, Inc.
Moderate riskThis product could cause temporary or reversible health problems — stop using it.What you should do
Stop using the affected lot and contact the recalling firm for the return or refund process. Check the FDA enforcement report for lot-level detail.
Firm contact: Intuitive Surgical, Inc. · 1266 Kifer Rd Bldg 101 · Sunnyvale, CA · 94086-5304
Is this the product you have?
- EndoWrist Suction Irrigator, Single Use Instrument
- Part Number480299-04. An accessory to the EndoWrist Surgical System, used in endoscopic surgery
- Lot codes and dates
- LotsT10180226 and onward
- Part Numbers480299-04 (UDI 00886874114810)
- Amount recalled
- 3108 units (518 boxes of 6 units)
Where it was sold
- Nationwide
Why it was recalled
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.
This product could cause temporary or reversible health problems — stop using it.
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