Reported Apr 24, 2019 · Terminated
Obturator (long cone), Part number 25162 Product Usage: The obturator is a component of the Flex Rectoscope which is an…
Medrobotics Corporation
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: Medrobotics Corporation · 475 Paramount Dr · Raynham, MA · 02767-5178
Is this the product you have?
- Obturator (long cone)
- Part number 25162 Product UsageThe obturator is a component of the Flex Rectoscope which is an accessory to the Flex Robotic System. The Medrobotics Flex Robotic System is intended to provide robot-assisted control of the Flex Colorectal Drive during visualization of and surgical site access to the anus, rectum and distal colon. The Flex Robotic System is intended for use in adults (e22 years of age). The Flex Colorectal Drive is intended for robot-assisted visualization of and surgical site access to the anus, rectum, and distal colon in adults (e22 years of age). The Flex Colorectal Drive also provides accessory channels for compatible flexible instruments used in surgery
- Lot codes and dates
lots 18832-1719042-0719042-0119199-0118832-1719669-0519684-05
- Amount recalled
- 35
This recall covers 2 products
The agency filed one notice per product. You are reading one of them; the other one is below.
Where it was sold
Why it was recalled
The weld may break, resulting in the rod separating from the cone of the long and short cone Obturators.
This product could cause temporary or reversible health problems — stop using it.
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The guide adds the identifying codes laid out for scanning, symptoms to watch for, a timeline, and news coverage of this recall.
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