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

Recall date

April 1, 2016

Source

U.S. Food & Drug Administration (FDA) — enforcement report

Recall number

Z-1621-2016

FDA classification

Class II

Brand / firm

Applied Medical Resources Corp

Sold / distributed

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,…

Why it was recalled

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

Class II means using this product may cause temporary or medically reversible health problems; the chance of serious harm is remote.

What was recalled

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