Recall Z-0766-2009 ยท CAI Circuit, Breathing (W Connector, Adaptor, Y Piece)
King Systems Corp.
King Systems Universal Flex2 Breathing Circuit, Latex Free, 40 per case, King Systems Corporation, Noblesville, IN; REF # DF4116R-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.
| Date | Feb 3, 2009 (initiated Aug 1, 2008) |
| Status | Terminated |
| Reason | 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 | 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 | Approx. 500,000 units of all products. |
| Distribution | Worldwide Distribution - including USA and countries of Australia, Colombia, Germany, Netherlands, and Peru. |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
This recall record lists no 510(k) number.