Applied Medical Resources Corp recalls Direct Drive Clip Applier CA090, indicated for ligation of tubular structures or vessels in laparoscopic and general sur

Recalled May 18, 2016 · FDA recall Z-1621-2016 · Applied Medical Resources

Hazard

Increased customer complaints indicating inconsistent clip application; may lead to unoccluded vessels. · FDA Class II

Units

559,274

Sold at

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

Description

Increased customer complaints indicating inconsistent clip application; may lead to unoccluded vessels.

Product

Direct Drive Clip Applier CA090, indicated for ligation of tubular structures or vessels in laparoscopic and general surgical procedures. Distributed individually and in kits.

Manufacturer(s)

Applied Medical Resources Corp

Source: U.S. Food and Drug Administration. Official recall notice on fda.gov →