FDA-Device2022-08-10Class II
PRESTIGE RETRACTION GRASPER, W/PORT DUAL ACTION, ROTATING 5mm DIAM., 36cm LENGTH. Product Code 8361-10
Aesculap Implant Systems LLC
Hazard
Endoscopic graspers may become separated at the weld from handle to the shaft of the device.
Sold states
United States Nationwide distribution in the states of AK, AL, AR, AZ, CA, CO, CT, DE, FL, GA, HI, IA, ID, IL, IN, KS, KY, LA, MA, MD, ME, MI, MN, MO, NC, NE, NH, NJ, NM, NV, NY, OH, OK, OR, PA, RI, SC, SD, TN, TX, UT, VA, WA, WI, WV, WY, Washington DC and Puerto Rico.
Affected count
399
Manufactured in
3773 Corporate Pkwy, N/A, Center Valley, PA, United States
Products
PRESTIGE RETRACTION GRASPER, W/PORT DUAL ACTION, ROTATING 5mm DIAM., 36cm LENGTH. Product Code 8361-10
Official notice
https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-1482-2022Don't want to check this manually?
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