Recall Z-1681-2019— King Systems Corp. dba Ambu, Inc.
Class II · Terminated
Class II FDA medical device recall by King Systems Corp. dba Ambu, Inc., initiated 2019-01-04, terminated 2020-04-20. FDA's recall record names no specific 510(k) clearance for this event. Product: King LTS-D Kit Size 1, Model Number KLTSD431. Reason: Size 0 products were incorrectly packaged and labeled as a size 1 products..
- Recalling firm
- King Systems Corp. dba Ambu, Inc.
- Classification
- Class II
- Status
- Terminated
- Initiated
- 2019-01-04
- Terminated
- 2020-04-20
- Firm location
- Noblesville, IN, United States
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.
Data sourced from openFDA. This site is unofficial and independent of the FDA.