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Class 2 Device Recall King Systems Universal Flex2 Breathing Circuit |
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Date Initiated by Firm |
August 01, 2008 |
Date Posted |
February 03, 2009 |
Recall Status1 |
Terminated 3 on November 12, 2009 |
Recall Number |
Z-0774-2009 |
Recall Event ID |
48991 |
Product Classification |
Breathing Circuit - Product Code CAI
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Product |
King Systems Universal Flex2 Breathing Circuit, Latex Free, 50 per case, King Systems Corporation, Noblesville, IN; REF # DFY170-61.
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 IKCW4 and IKQ30. |
Recalling Firm/ Manufacturer |
King Systems Corp. 15011 Herriman Blvd Noblesville IN 46060
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For Additional Information Contact |
317-776-6823
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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.
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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
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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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