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American Catheter Corp recalls American Catheter / Cholangiogram Catheter 9100 Series.
Recalled July 29, 2015 · FDA recall Z-2191-2015 · American Catheter
Hazard
Catheters were not sealed before sterilization. and was not detected through subsequent acceptance activities, product release and distribution. · FDA Class II
Units
890 devices.
Sold at
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.
Description
Catheters were not sealed before sterilization. and was not detected through subsequent acceptance activities, product release and distribution.
Product
American Catheter / Cholangiogram Catheter 9100 Series.
Manufacturer(s)
American Catheter Corp
Source: U.S. Food and Drug Administration. Official recall notice on fda.gov →