FDA Medical Device Recalls (openFDA)
King Systems Corp. dba Ambu, Inc.: King LTS-D Kit Size 1, Model Number KLTSD431
- Recall number
- Z-1681-2019
- Recalling firm
- King Systems Corp. dba Ambu, Inc.
- Product
- King LTS-D Kit Size 1, Model Number KLTSD431
- Status
- Terminated
- Initiated
- 2019-01-04
- Posted
- not on file
- Terminated
- 2020-04-20
- Reason
- Size 0 products were incorrectly packaged and labeled as a size 1 products.
- Root cause
- Packaging process control
- Action
- Urgent Medical Device Recall notification letters were sent to customers beginning 1/4/19.
- Quantity
- 270
- Distribution
- The products were distributed to the following US states: CA, CT, FL, IA, IN, MD, MS, NC, PA, TX, and WI.
- Lot, serial or model codes
- Lot code 1000147351
- 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