FDA Medical Device Recalls (openFDA)
King Systems Corp.: KING LAD SILI CONE SINGLE USE, King Systems, 10 devices/case, ETO Sterile Size 3 / Child Silicone King LAD Patient Size: 30-50kg Product Usage: Laryngeal airway
- Recall number
- Z-0419-2013
- Recalling firm
- King Systems Corp.
- Product
- KING LAD SILI CONE SINGLE USE, King Systems, 10 devices/case, ETO Sterile Size 3 / Child Silicone King LAD Patient Size: 30-50kg Product Usage: Laryngeal airway
- Status
- Terminated
- Initiated
- 2012-11-02
- Posted
- 2012-11-21
- Terminated
- 2013-05-28
- Reason
- The firm received two complaints from a user facility in New Jersey regarding color-coded EtO sterilization indicators on the primary device packaging that did not undergo the expected color change. The complainant reported devices that had pink color indicators when the product packaging specified that the color should change from pink to yellow (or brown) if the product had subjected to an EtO
- Root cause
- Nonconforming Material/Component
- Action
- King Systems sent an URGENT MEDICAL DEVICE RECALL NOTIFICATION letter dated October 31, 2012 to all affected consignees via email. The letter identified affected product, problem and actions to be taken. The letter states that further use and/or distribution of any remaining product affected by this recall should cease immediately. The letter instructs customers to destroy all of the affected products and indicate the destruction by signing and returning the attached forms using the enclosed self-addressed envelope. For questions contact your King Systems customer service representative at 800-642-5464.
- Quantity
- 263 cases of product. (2,630 devices)
- Distribution
- US Nationwide Distribution - WI, TX, NY, MO, IN, KY, FL, NJ, PA, TN, and NC
- Lot, serial or model codes
- REF: LAD-303, Lot #K120618
- 510(k) numbers
- not on file
- PMA numbers
- not on file
- Product code
- CAE
- 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