Class 2 Device Recall King Systems Universal Flex2 Breathing Circuit

• Date Initiated by Firm: August 01, 2008
• Date Posted: February 03, 2009
• Recall Status: Terminated on November 12, 2009
• Recall Number: Z-0701-2009
• Recall Event ID: 48991
• Product Classification: Breathing Circuit - Product Code CAI
• Product: King Systems Universal Flex2 Breathing Circuit, Latex Free, 50 per case, King Systems Corporation, Noblesville, IN; REF # DF270-6121Z.; ; This breathing circuit is a device intended to administer medical gases and/or anesthetic gases to a patient during anesthesia for inhalation, or medical gases to a patient during respiratory care inhalation.
• Code Information: Lots IKUS4 and IL4K6.
• Recalling Firm/ Manufacturer: King Systems Corp.; 15011 Herriman Blvd; Noblesville IN 46060
• For Additional Information Contact: 317-776-6823
• Manufacturer Reason for Recall: The inner line may be severed or broken into two pieces, thus hindering the delivery of oxygen and anesthetics to the patient and possibly elevated patient carbon dioxide levels.
• FDA Determined Cause: Pending
• Action: Consignees were notified by an Urgent Product Recall letter on or about 7/29/2008 to cease sales, notify their customers to the hospital level, and to return product on hand.
• Quantity in Commerce: Approx. 500,000 units of all products.
• Distribution: Worldwide Distribution - including USA and countries of Australia, Colombia, Germany, Netherlands, and Peru.
• 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.