Recall Z-0720-2022— Sunstar Americas, Inc.
Class II · Terminated
Class II FDA medical device recall by Sunstar Americas, Inc., initiated 2022-01-14, terminated 2023-08-28. FDA's recall record names no specific 510(k) clearance for this event. Product: BUTLER Clear Dip, 12 bottles/case. Reason: Product lacks premarket clearance..
- Recalling firm
- Sunstar Americas, Inc.
- Classification
- Class II
- Status
- Terminated
- Initiated
- 2022-01-14
- Terminated
- 2023-08-28
- Firm location
- Schaumburg, IL, United States
Product description
BUTLER Clear Dip, 12 bottles/case
Reason for recall
Product lacks premarket clearance.
Data sourced from openFDA. This site is unofficial and independent of the FDA.