FDA-Device2015-07-29Class II
American Catheter / Cholangiogram Catheter 9100 Series.
American Catheter Corp
Hazard
Catheters were not sealed before sterilization. and was not detected through subsequent acceptance activities, product release and distribution.
Sold states
Distributed in the states of AL, AK, CA, CO, FL, GA, HI, IL, KS, LA, MI, MO, MT, NJ, OH, OK, SC, TN, TX, WA, and WI.
Affected count
890 devices.
Manufactured in
13047 S Highway 475, N/A, Ocala, FL, United States
Products
American Catheter / Cholangiogram Catheter 9100 Series.
Official notice
https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-2191-2015Don't want to check this manually?
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