FDA recall Z-2159-2020

Applied Medical Resources Corp · Class II · device

Product

Epix latis GRASPER, 5mm x 45 cm, REF: C4140, Qty: 10, Sterile R, CE, Rx ONLY, UDI: (01)00607915110154

Reason for recall

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.

Distribution

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

Key facts

Status
Terminated
Initiation date
2020-03-17
Report date
2020-06-03
Termination date
2022-02-17
Voluntary/Mandated
Voluntary: Firm initiated
Location
Rancho Santa Margarita, CA, United States

Primary source

https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-2159-2020