FDA Medical Device Recalls (openFDA)
King Systems Corp.: Face Tent with 15 mm Adapter, REF S-MD126, Manufacturer: King Systems Nobleville, IN. An oxygen mask is a device placed over a patient's nose, mouth, or tracheostomy to administer oxygen or aerosols.
- Recall number
- Z-1888-2011
- Recalling firm
- King Systems Corp.
- Product
- Face Tent with 15 mm Adapter, REF S-MD126, Manufacturer: King Systems Nobleville, IN. An oxygen mask is a device placed over a patient's nose, mouth, or tracheostomy to administer oxygen or aerosols.
- Status
- Terminated
- Initiated
- 2011-01-24
- Posted
- 2011-04-06
- Terminated
- 2012-08-14
- Reason
- The firm is conducting a subrecall of facetent masks because the masks could have a sticky substance on the inside or outside of the mask that may manifest itself 6-8 months after the manufacture date of the product. The sticky substance could result in inconvenience or in some remote cases cause patient harm.
- Root cause
- Other
- Action
- The firm issued an URGENT PRODUCT RECALL letter dated 1/24/2011. The letter identified the affected product and stated the reason for recall. The letter instructed consignees to cease all sales, to immediately examine their inventory, and to quarantine the product. The letter included a response form that is to be completed and returned. Distributors were instructed to inform their customers of the recall. King Systems Customer Service Department should be contacted at 1-800-642-5464 in order to receive a Return Authorization Number. The letter stated that consignees should return the recalled products to King Systems and the firm will replace the products or provide an acceptable substitute. Customers should contact Customer Service if they have any questions regarding the recall and the letter.
- Quantity
- 76 cases of 5 per case 380
- Distribution
- Nationwide Distribution -- NM, GA, TX, FL, IL, VA and LA.
- Lot, serial or model codes
- IPCF2, IQ3Y0, IQ698, IQPU1, IQUZ0, IR2I7, IRFY3, ISEX6, ISJN6 and IT3Q0.
- 510(k) numbers
- not on file
- PMA numbers
- not on file
- Product code
- BYG
- 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