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U.S. Department of Health and Human Services

Class 2 Device Recall King Systems Universal Flex2 Breathing Circuit

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  Class 2 Device Recall King Systems Universal Flex2 Breathing Circuit see related information
Date Initiated by Firm August 01, 2008
Date Posted February 03, 2009
Recall Status1 Terminated 3 on November 12, 2009
Recall Number Z-0758-2009
Recall Event ID 48991
Product Classification Breathing Circuit - Product Code CAI
Product King Systems Universal Flex2 Breathing Circuit, Latex Free, 40 per case, King Systems Corporation, Noblesville, IN; REF # DF3116-6021Z.

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 Lot IL1R3.
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 2
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.
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