Recall Z-0810-2021— Bioventus, LLC
Class II · Terminated
Class II FDA medical device recall by Bioventus, LLC, initiated 2020-12-17, terminated 2024-08-07. FDA's recall record names no specific 510(k) clearance for this event. Product: EXOGEN Ultrasound Coupling Gel. Reason: Product may contain white particulates that are microbial in nature..
- Recalling firm
- Bioventus, LLC
- Classification
- Class II
- Status
- Terminated
- Initiated
- 2020-12-17
- Terminated
- 2024-08-07
- Firm location
- Cordova, TN, United States
Product description
EXOGEN Ultrasound Coupling Gel
Reason for recall
Product may contain white particulates that are microbial in nature.
Data sourced from openFDA. This site is unofficial and independent of the FDA.