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U.S. Department of Health and Human Services

Class 2 Device Recall Cardiac Imaging Catheter

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  Class 2 Device Recall Cardiac Imaging Catheter see related information
Date Initiated by Firm August 08, 2008
Date Posting Updated January 13, 2009
Recall Status1 Terminated 3 on April 26, 2011
Recall Number Z-0551-2009
Recall Event ID 49510
510(K)Number K043453  
Product Classification Catheter - Product Code NLI
Product Cardiac Imaging Catheter
Model #'s:
ACU08267996 and
Intended for intravascular or intracardiac ultrasound imaging in order to provide visualization of vascular anatomy, cardiac and great vessel anatomy and physiology, or other devices in the heart.
Code Information n/a
Recalling Firm/
Sterilmed Inc
11400 73rd Ave N Ste 100
Osseo MN 55369-5562
For Additional Information Contact
Manufacturer Reason
for Recall
SteriMed, Inc is conducting a product removal of a small group of devices individually packaged and sealed within a pouch. The removal is being conducted because the possibility exists that some of the pouches were not properly sealed on one end. A breach in packaging seal or a failure in packaging integrity has the possibility of risk to the patient in terms of transmitting organisms capable
FDA Determined
Cause 2
Packaging process control
Action Consignees were notified of the recall via verbal communication in person by on-site technician and or their local sales representative on 8/8/08. Others were contacted via fax or e-mail followed by on-site visits 8/11/08. SteriMed also provided consignees (Materials Manager/Risk Manager) with a "Urgent Product Removal" recall letter (August 14, 2008) in person informing them of the potential of receiving affected product. Included in the Product Removal Notification was a Customer Reply Form to inventory quantity of product received and quantity returned. Contact SterilMed, Inc. at 1-888-541-0078 for assistance.
Quantity in Commerce 58
Distribution AL, AZ, CA, CO, CT, FL, GA, IA, ID, IL, IN, KS, KY, MA, MI, MN, MO, MS, MT, NC, ND, NE, NJ, NY, OH, OK, OR, PA, SC, SD, TN, TX, UT, WA, WI, and WV OUS: CANADA
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.
510(K) Database 510(K)s with Product Code = NLI and Original Applicant = STERILMED, INC.