American Catheter Corp recalls American Catheter / Cholangiogram Catheter 9100 Series.

Recall date

March 17, 2015

Source

U.S. Food & Drug Administration (FDA) — enforcement report

Recall number

Z-2191-2015

FDA classification

Class II

Brand / firm

American Catheter Corp

Sold / distributed

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.

Why it was recalled

Catheters were not sealed before sterilization. and was not detected through subsequent acceptance activities, product release and distribution.

Class II means using this product may cause temporary or medically reversible health problems; the chance of serious harm is remote.

What was recalled

American Catheter / Cholangiogram Catheter 9100 Series.