Recalls / —
—#75781
Product
King Systems 37" Universal Flex2 Extension Kit, 50 per case, King Systems Corporation, Noblesville, IN; REF # XF37.
- FDA product code
- CAI — Circuit, Breathing (W Connector, Adaptor, Y Piece)
- Device class
- Class 1
- Medical specialty
- Anesthesiology
- Affected lot / code info
- Lots IKER5, IKGB8, IKIC9, IKLE2, IKNL9, IKSN1, IKTX7, IKY04, IL023, IL1Y4 and IL591.
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 #75781. The FDA issues recall classifications as health-hazard assessments, not legal findings; for legal claims consult a licensed attorney.