Class 2 Device Recall Reprocessed Balloon Inflation Device

• Date Initiated by Firm: August 08, 2008
• Date Posted: January 13, 2009
• Recall Status: Terminated on April 26, 2011
• Recall Number: Z-0546-2009
• Recall Event ID: 49510
• 510(K)Number: K053188
• Product Classification: Balloon Inflation Device - Product Code NKU
• Product: Balloon Inflation Device Model #'s: MED15-105 MED15-106 and SCI04527-01 The reprocessed Balloon inflation device is intended for use with balloon dilatation catheters to create and monitor pressure in the ballon and to deflate the ballon.
• Code Information: n/a
• Recalling Firm/ Manufacturer: Sterilmed Inc; 11400 73rd Ave N Ste 100; Osseo MN 55369-5562
• For Additional Information Contact: 763-488-3400
• 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: 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: 85
• 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 = NKU