Class 2 Device Recall A M Systems ViroMax viral/bacterial filter

• Date Initiated by Firm: March 31, 2010
• Date Posted: January 11, 2012
• Recall Status: Terminated on January 05, 2012
• Recall Number: Z-0308-2012
• Recall Event ID: 55294
• 510(K)Number: K063526
• Product Classification: Filter, bacterial, breathing-circuit - Product Code CAH
• Product: ViroMax viral/bacterial filter. The filter reduces the risk of infection due to cross-contamination between patients For use on all patient populations in conjunction with other respiratory devices containing standard 15mm and/or 22mm fittings (such as breathing circuits) to filter respiratory gases where infection from airborne bacteria and viruses is a concern. Disposable, for single patient use only.
• Code Information: Lot numbers: 551278, 551311, 551355, 551425, 551432, 551452, 551635, 551658, 551699, 551704, 551727, 551732, 551746, 551800, 551879, 551905, 551954 and 552095.
• Recalling Firm/ Manufacturer: A M Systems Inc; 131 Business Park Loop; P.O. Box 850; Sequim WA 98382-0850
• For Additional Information Contact: Robert Thompson; 360-683-8300
• Manufacturer Reason for Recall: Some ViroMax viral/bacterial filters are leaking at the point where the two halves of the filter are ultrasonically bonded together.
• FDA Determined Cause: Nonconforming Material/Component
• Action: A - M Systems sent a Urgent Notification of Product Recall/Correction dated March 31, 2010, to all affected customers. The letter identificed the product the problem and the action needed to be taken by the customer. Customers were instructed to cease use and/or distribution of the affected product and to immediately notify any of their sub-accounts with the same information. Customers are asked to provide A - M Systems with the amount distributed and amount remaining in inventory and to then destroy or discard any remaining product in their possession. Please call 360.683.8300, if you have any questions or concerns.
• Quantity in Commerce: 37800
• Distribution: Worldwide Distribution -- USA ( nationwide) including the states of AZ, CA, FL, KY, MA, MI, NC, OH, OR, and WI., and the countries Canada, Mexico, and Taiwan.
• 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 = CAH