FDA-Device2020-06-03Class II
DR. THAMES - LAP CHOLE, REF: K0880, UDI: (01)30607915139620
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
21 units
Manufactured in
22872 Avenida Empresa, N/A, Rancho Santa Margarita, CA, United States
Products
DR. THAMES - LAP CHOLE, REF: K0880, UDI: (01)30607915139620
Official notice
https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-2160-2020Don't want to check this manually?
We email you a Sunday digest of new federal recalls relevant to parents — free, no credit card. Or upgrade to as-it-happens alerts for the brands you actually own.
Get the Sunday Brief