—#75647

Product

King Systems Universal Flex2 Breathing Circuit, Latex Free, 50 per case, King Systems Corporation, Noblesville, IN; REF # DF475-61Z. 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 product code: CAI — Circuit, Breathing (W Connector, Adaptor, Y Piece)
Device class: Class 1
Medical specialty: Anesthesiology
Affected lot / code info: Lots IKAA0, IKCC6, IKDS7, IKG80, IKI90, IKK94, IKMT9, IKP76, IKQL8, IKS08, IKU49, IKXI6, IL101, IL4L9, IL7J5 and ILBP2.

Why it was recalled

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.

Root cause (FDA determination)

Pending

Action the firm took

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.

Recalling firm

Firm: King Systems Corp.
Address: 15011 Herriman Blvd, Noblesville, Indiana 46060

Distribution

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

Timeline

Recall initiated: 2008-08-01
Posted by FDA: 2009-02-03
Terminated: 2009-11-12
Status: —

Source: openFDA Device Recall endpoint. Recall record ID #75647. The FDA issues recall classifications as health-hazard assessments, not legal findings; for legal claims consult a licensed attorney.