FDA-Device2020-06-03Class II
Epix latis GRASPER, 5mm x 45 cm, REF: C4140, Qty: 10, Sterile R, CE, Rx ONLY, UDI: (01)00607915110154
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
4320 units
Manufactured in
22872 Avenida Empresa, N/A, Rancho Santa Margarita, CA, United States
Products
Epix latis GRASPER, 5mm x 45 cm, REF: C4140, Qty: 10, Sterile R, CE, Rx ONLY, UDI: (01)00607915110154
Official notice
https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-2159-2020Don't want to check this manually?
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