FDA-Device2014-12-17Class II
A trocar is a sharp-pointed instrument used with a cannula for piercing a vessel or chamber to facilitate insertion of the cannula sold under the Symmetry Surgical, CareFusion, and Ambler Surgical brand names.
Instrumed International, Inc.
Hazard
The reason these devices are being withdrawn from the market by Instrumed is that Instrumed did not market these devices prior to September 26, 1976, and therefore, does not meet all FDA requirements to market the devices as "Pre-Amendment" devices.
Sold states
Nationwide Distribution including AZ, CA, FL, IL, KS, MI, NC, OH, PA, TN, TX, and VA.
Affected count
11 trocars
Manufactured in
626 Cooper Ct, N/A, Schaumburg, IL, United States
Products
A trocar is a sharp-pointed instrument used with a cannula for piercing a vessel or chamber to facilitate insertion of the cannula sold under the Symmetry Surgical, CareFusion, and Ambler Surgical brand names.
Official notice
https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-0535-2015Don't want to check this manually?
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