FDA-Device2020-06-03Class II

Clip Applier Kit, REF: K2887, UDI: (01)30607915139132(17)220822(30)1(10)

Applied Medical Resources Corp
Hazard

There may be a slightly protruding rivet on the distal end of the laparoscopic grasper which has the potential for tissue to catch on it during use and lead to tissue damage.

Sold states
US: AL, AR, AZ, CA, CO, CT, FL, GA, HI, IL, IN, KS, KY, LA, MA, MD, MI, MN, MO, MS, MT, NC, ND, NE, NJ, NM, NY, OH, OK, OR, PA, PR, RI, SC, SD, TN, TX, UT, VA, WA, WI, WV, WY OUS: Argentina, Australia, Austria, Belgium, Canada, Chile, Costa Rica, Denmark, France, Germany, Greece, Hong Kong, India, Ireland, Israel, Italy, Latvia, Liechtenstein, Luxembourg, Netherlands, New Zealand, Peru, Portugal, Serbia, Singapore, South Africa, Spain, Thailand, United Kingdom
Affected count
12 units
Manufactured in
22872 Avenida Empresa, N/A, Rancho Santa Margarita, CA, United States
Products
Clip Applier Kit, REF: K2887, UDI: (01)30607915139132(17)220822(30)1(10)

Official notice

https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-2161-2020

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