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U.S. Department of Health and Human Services

Class 2 Device Recall American Catheter 9100 Series

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  Class 2 Device Recall American Catheter 9100 Series see related information
Date Initiated by Firm March 17, 2015
Date Posted July 22, 2015
Recall Status1 Terminated 3 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/
American Catheter Corp
13047 S Highway 475
Ocala FL 34480-8503
For Additional Information Contact Todd Cantine
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 2
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.