Z-0816-2009

King Systems 72" Universal Flex2 Extension Kit, 50 per case, King Systems Corporation, Noblesville, IN; REF #...

Name: Z-0816-2009 King Systems 72" Universal Flex2 Extension Kit, 50 per case, King Systems Corporation, Noblesville, IN; REF #...
Creator: King Systems Corp.
Published: 2008-08-01
License: https://open.fda.gov/license/

King Systems Corporation. / initiated 2008-08-01 / Terminated

FDA source

King Systems Corp. began a recall of King Systems 72" Universal Flex2 Extension Kit, 50 per case, King Systems Corporation, Noblesville, IN; REF # XF75 on 2008-08-01. The reason FDA records is "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". As of 2026-09-10, the recall status on record is Terminated.

Recall record

Recall number: Z-0816-2009
Status: Terminated
Initiated: 2008-08-01
Posted: 2009-02-03
Terminated: 2009-11-12
Recalling firm: King Systems Corporation.
Product: King Systems 72" Universal Flex2 Extension Kit, 50 per case, King Systems Corporation, Noblesville, IN; REF # XF75.
Product code: CAI Circuit, Breathing (W Connector, Adaptor, Y Piece)
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 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 in commerce: Approx. 500,000 units of all products.
Distribution: Worldwide Distribution - including USA and countries of Australia, Colombia, Germany, Netherlands, and Peru.
Product codes and lots: Lots IKAE1, IKCJ4, IKER6, IKGC0, IKIJ7, IKJK6, IKMI3, IKQ81, IKUX4, IKVS2, IKY06, IL161, IL1Y6, IL383, IL7N9 and IL8Y9.

Product code CAI

The FDA recall record names no cleared device, and no clearance has been matched to it.

MDM coverage of this record lists here, newest first.

About this record

Sourced from the FDA device recall database and the FDA enforcement reports, both ingested from openFDA. The recall record supplies the product, the reason and the product code; the enforcement report supplies the classification. The two datasets are exported by FDA on different days, and the date above is the older of the two, so nothing on this page is newer than it says.

MDM adds the root cause tag, derived from FDA’s own root cause text, and the cross-links to the product code, the clearances named on the record and MDM coverage. Where a recall has not been joined to an enforcement report, no classification is shown.

Data as of 2026-10-07, the FDA export date for this dataset. Page last changed 2026-09-05. View this recall on fda.gov (opens on fda.gov)