Recall Z-1681-2019
King Systems Corp. dba Ambu, Inc. · initiated January 4, 2019
Class II – products that might cause a temporary health problem or pose a slight threat of a serious nature
Product
King LTS-D Kit Size 1, Model Number KLTSD431
Codes / lots: Lot code 1000147351
Reason for recall
Size 0 products were incorrectly packaged and labeled as a size 1 products.
FDA-determined cause: Packaging process control
Action taken
Urgent Medical Device Recall notification letters were sent to customers beginning 1/4/19.
Details
- Recall number
- Z-1681-2019
- Initiated
- January 4, 2019
- Terminated
- April 20, 2020
- Product code
- CAE – Airway, Oropharyngeal, Anesthesiology
- Quantity
- 270
- Distribution
- The products were distributed to the following US states: CA, CT, FL, IA, IN, MD, MS, NC, PA, TX, and WI.
- Recalling firm
- King Systems Corp. dba Ambu, Inc., Noblesville, IN