FDA Medical Device Recalls (openFDA)
King Systems Corp.: King Systems Universal Flex2 Breathing Circuit, Latex Free, 40 per case, King Systems Corporation, Noblesville, IN; REF # DF4116-6121Z. 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.
- Recall number
- Z-0763-2009
- Recalling firm
- King Systems Corp.
- Product
- King Systems Universal Flex2 Breathing Circuit, Latex Free, 40 per case, King Systems Corporation, Noblesville, IN; REF # DF4116-6121Z. 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.
- Status
- Terminated
- Initiated
- 2008-08-01
- Posted
- 2009-02-03
- Terminated
- 2009-11-12
- 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.
- Lot, serial or model codes
- Lots IKS04, IKW69, IL1S3 and ILAY2.
- 510(k) numbers
- not on file
- PMA numbers
- not on file
- Product code
- CAI
- Firm FEI
- 1824226
- Firm city
- Noblesville
- Firm state
- IN
- Firm country
- not on file
Where this comes from
- Register
- FDA Medical Device Recalls (openFDA)
- Publisher
- U.S. Food and Drug Administration (openFDA)
- File
- device-recall-0001-of-0001.json.zip
- sha256
- b87518bfe2e8
- Size
- 288210821 bytes
- Published
- 2026-09-28
- Read
- 2026-09-29T08:25:23.626Z
- Source file
- Source file retained · verify
- Refresh due
- 2026-10-06
Unless otherwise noted, the content, data, documentation, code, and related materials on openFDA is public domain and made available with a Creative Commons CC0 1.0 Universal dedication.
Cite as
FDA Medical Device Recalls (openFDA) (U.S. Food and Drug Administration (openFDA)), device-recall-0001-of-0001.json.zip, sha256 b87518bfe2e8, published 2026-09-28