Z-1681-2019 Class II Terminated
FDA device recall Z-1681-2019 was initiated by King Systems Corp. dba Ambu, Inc. on January 4, 2019 and is designated Class II. Reason for recall: Size 0 products were incorrectly packaged and labeled as a size 1 products. The recall status is terminated (terminated April 20, 2020). Affected quantity: 270.
Recall Details
- Product Type
- Devices
- Report Date
- June 5, 2019
- Initiation Date
- January 4, 2019
- Termination Date
- April 20, 2020
- Voluntary/Mandated
- Voluntary: Firm initiated
- Product Quantity
- 270
Product Description
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 Pattern
The products were distributed to the following US states: CA, CT, FL, IA, IN, MD, MS, NC, PA, TX, and WI.
Code Information
Lot code 1000147351