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Terminated

King Systems Universal Flex2 Breathing Circuit, 50 per case, King Systems Corporation, Noblesville, IN; REF # AL-DF370-61. 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.

FDA Recall Z-0684-2009 · Posted 2009-02-03

Recalling FirmKing Systems Corp.
Recall StatusTerminated
Product CodeCAI
Date Initiated2008-08-01
Date Terminated2009-11-12
Product QuantityApprox. 500,000 units of all products.

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.

Firm 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.

Root Cause

Pending

Distribution Pattern

Worldwide Distribution - including USA and countries of Australia, Colombia, Germany, Netherlands, and Peru.

Official Source

View FDA Recall →

Source: FDA Enforcement Report / Recall database. Always confirm against the official FDA record.

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