FDA-Device2016-05-18Class II
Direct Drive Clip Applier CA090, indicated for ligation of tubular structures or vessels in laparoscopic and general surgical procedures. Distributed individually and in kits.
Applied Medical Resources Corp
Hazard
Increased customer complaints indicating inconsistent clip application; may lead to unoccluded vessels.
Sold states
U.S. distribution to the following: IL, IN, WY, PA, CA, LA, MN, AZ, OH, OR, CT, WI, NC, AK, NE, MI, KS, FL, MN, TN, SC, MA, MD, KY, TX, GA, TX, NJ, MO, CO, MS, MT, ID, ME, VA, NY, UT, MI, AL, PR, NM, DE, OK, WA, DC, NH, AR Foreign distribution to the following; Australia, Spain, New Zealand, Italy, Israel, Estonia, United Arab Emirates, Germany, Netherlands, France, Kuwait, Korea, Qatar, Mexico, Switzerland, Austria, Bahrain, Lebanon, Brazil, Belgium, United Kingdom, Finland, Japan, Argentina, Ireland, Iran, Denmark, Norway, Colombia, Serbia, Uruguay, Sweden, Canada, Costa Rica, South Africa, Czech Republic, Chile, Finland, India, Thailand, Malaysia
Affected count
559,274
Manufactured in
22872 Avenida Empresa, N/A, Rancho Santa Margarita, CA, United States
Products
Direct Drive Clip Applier CA090, indicated for ligation of tubular structures or vessels in laparoscopic and general surgical procedures. Distributed individually and in kits.
Official notice
https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-1621-2016Don't want to check this manually?
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