Class 2 Device Recall American Catheter 9100 Series

• Date Initiated by Firm: March 17, 2015
• Date Posted: July 22, 2015
• Recall Status: Terminated on December 14, 2016
• Recall Number: Z-2191-2015
• Recall Event ID: 71263
• Product Classification: Catheter, cholangiography - Product Code GBZ
• Product: American Catheter / Cholangiogram Catheter 9100 Series.
• Code Information: Product Number is 9100, Lot # 14101601.
• Recalling Firm/ Manufacturer: American Catheter Corp; 13047 S Highway 475; Ocala FL 34480-8503
• For Additional Information Contact: Todd Cantine; 800-345-6714
• Manufacturer Reason for Recall: Catheters were not sealed before sterilization. and was not detected through subsequent acceptance activities, product release and distribution.
• FDA Determined Cause: Process control
• Action: Consignees were contacted by telephone of the affected lot number and sent a Recall Script dated 3/17/2015 giving instructions how to respond to this recall.
• Quantity in Commerce: 890 devices.
• Distribution: 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.
• Total Product Life Cycle: TPLC Device Report

¹ A record in this database is created when a firm initiates a correction or removal action. The record is updated if the FDA identifies a violation and classifies the action as a recall, and it is updated for a final time when the recall is terminated. Learn more about medical device recalls.
² Per FDA policy, recall cause determinations are subject to modification up to the point of termination of the recall.
³ For details about termination of a recall see Code of Federal Regulations (CFR) Title 21 §7.55.