| Class 2 Device Recall King Systems Universal Flex2 Breathing Circuit | |
Date Initiated by Firm | August 01, 2008 |
Date Posted | February 03, 2009 |
Recall Status1 |
Terminated 3 on November 12, 2009 |
Recall Number | Z-0750-2009 |
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 # DF476-6121Z.
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 IKB46, IKCW1, IKIJ1, IKP77, IKR39, IKWT4, IKZ43, IL102, IL4B2, IL6X2 and ILAP0. |
Recalling Firm/ Manufacturer |
King Systems Corp. 15011 Herriman Blvd Noblesville IN 46060
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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 |
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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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