FDA-Device2022-07-20Class II
PALMAZ GENESIS Transhepatic Biliary Stent on OPTA PRO .035" Delivery System, Catalog numbers PG2990BPS, PG2990BPX, PG3990BPS, PG3990BPX.
Cordis US Corp
Hazard
Potential for stent dislodgement and associated failures related to two specific sizes of the device.
Sold states
US Nationwide distribution in the states of AL, AR, AZ, CA, CO, CT, DC, DE, FL, GA, HI, IA, IL, IN, KS, KY, LA, MA, MD, MI, MN, MO, MS, MT, NC, NE, NH, NJ, NV, NY, OH, OK, OR, PA, RI, SC, SD, TN, TX, VA, WA, WI, and WY. There was also government/military distribution.
Affected count
1,089 units
Manufactured in
14201 Nw 60th Ave, Miami Lakes, FL, United States
Products
PALMAZ GENESIS Transhepatic Biliary Stent on OPTA PRO .035" Delivery System, Catalog numbers PG2990BPS, PG2990BPX, PG3990BPS, PG3990BPX.
Official notice
https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-1363-2022Don't want to check this manually?
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