King Systems Universal Flex2 Breathing Circuit, 50 per case, King Systems Corporation, Noblesville, IN; REF # DF470-6113
FDA device recall Z-0730-2009 · posted 2009-02-03 · Terminated
Recall details
- Recalling firm
- King Systems Corp.
- 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.
- Action taken
- 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
- Status
- Terminated
- Product code
- CAI
- Quantity affected
- Approx. 500,000 units of all products.
- Distribution
- Worldwide Distribution - including USA and countries of Australia, Colombia, Germany, Netherlands, and Peru.
- Date initiated
- 2008-08-01
- Date posted
- 2009-02-03
- Date terminated
- 2009-11-12
- Location
- Noblesville, IN
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