Class 2 Device Recall Xenon Diagnostic Circuit Kits

• Date Initiated by Firm: April 16, 2010
• Date Posted: June 03, 2010
• Recall Status: Terminated on April 05, 2012
• Recall Number: Z-1754-2010
• Recall Event ID: 55527
• 510(K)Number: K063526
• Product Classification: filter, bacterial, breathing-circuit - Product Code CAH
• Product: Xenon Diagnostic Circuit Kits labeled as "Xenon Diagnostic Circuit", "Xenon Circuit", and Needleless Xenon Diagnostic Circuit" Manufactured for RAF MEDICAL, INC., (Model number's RAF2306, RAF2304, RAF2380, RAF2300, RAF2370, RAF2372, RAF2350, RAF2341, RAF2302, RAF2340 RAF2306, RAF2304, RAF2361), or Medico-Mart, Inc. ("Xenon Curcuit" Model number's 2304, 2306). Xenon Diagnostic Circuit Kit: Used in specific Nuclear Medicine Procedures. ViroMax: For use on all patient populations, in conjunction with other respiratory devices containing standard 15 mm and/or 22 mm fittings (such as breathing circuits and the like) to filter respiratory gases where infection from airborne bacteria and viruses is a concern.
• Code Information: Lot #'s for RAF Medical, Inc.: 1002092, 1001211, 1002011, 1002192, 1003081, 1003231, 1002012, 1003085, 1001263, 1003186,1004051, 1002112, 1003086, 1003082, 1003245, 1003291, 1002081, 1002111, 1001222, 1002193, 1003083, 1003241, 1002013, 1003084, 1003242, 1001181, 1003296, Lot #'s for Medico-Mart: 10020414, 1002191, 1003088
• Recalling Firm/ Manufacturer: Continental Medical Labs,Inc; 813 Ela Ave / PO Box 306; Waterford WI 53185-0306
• For Additional Information Contact: Jennifer Christensen; 262-534-2787
• Manufacturer Reason for Recall: CML, Inc. was notified by A-M Systems in a letter dated March 31, 2010 that they were recalling a component of their Xenon Kit (ViroMax viral and bacterial filter) because the filters may have a leak at the seam where the two halves of the filter are bonded together.
• FDA Determined Cause: Release of Material/Component prior to receiving test results
• Action: The firm, A-M Systems, sent two "URGENT: Notification of Product Recall/Correction" letters one dated March 31, 2010 and the other dated April 7, 2010 to customers. The letters described the product, problem and action to be taken by customers. Also enclosed was a list of the affected products that was sold to the consignee. The customer was instructed to cease further distribution or use of any remaining products from the listed lots, immediately notify any customers who received products from the lots, provide A-M Systems with the number of items distributed and still remaining in their inventory, once the number is provided the customer should destroy or discard any remaining product in their possession from these lot numbers. Please feel free to contact Robert Thompson by phone 360-683-8300 x302 or email: rthompson@a-msystems.com with any questions, comments or concerns.
• Quantity in Commerce: 5520
• Distribution: Nationwide distribution: 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.

• 510(K) Database: 510(K)s with Product Code = CAH