FDA-Device2018-05-23Class II
5mm Endopath Xcel with Optiview Technology, Bladeless Trocar with Stability Sleeve, 5mm, 150mm shaft length, 2B5XT
Ethicon Endo-Surgery Inc
Hazard
Use of the product with insufficient lubrication may prolong surgery due to trocar replacement. In addition, insufficient lubrication could result in a remote chance of introducing a minute particle if repeated insertions of the obturator or laparoscopic device damage the seal.
Sold states
Nationwide domestic distribution, including PR. International distribution to Saudi Arabia, United Arab Emirates, Belgium, Singapore, Taiwan, South Korea, Canada, Chile, Mexico, Japan, and Argentina.
Affected count
1500
Manufactured in
4545 Creek Rd, Blue Ash, OH, United States
Products
5mm Endopath Xcel with Optiview Technology, Bladeless Trocar with Stability Sleeve, 5mm, 150mm shaft length, 2B5XT
Official notice
https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-1887-2018Don't want to check this manually?
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