FDA recall Z-1681-2019
King Systems Corp. dba Ambu, Inc. · Class II · device
Product
King LTS-D Kit Size 1, Model Number KLTSD431
Reason for recall
Size 0 products were incorrectly packaged and labeled as a size 1 products.
Distribution
The products were distributed to the following US states: CA, CT, FL, IA, IN, MD, MS, NC, PA, TX, and WI.
Key facts
- Status
- Terminated
- Initiation date
- 2019-01-04
- Report date
- 2019-06-05
- Termination date
- 2020-04-20
- Voluntary/Mandated
- Voluntary: Firm initiated
- Location
- Noblesville, IN, United States
Primary source
https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-1681-2019