FDA Enforcement
Class II
Terminated
EXOGEN Ultrasound Coupling Gel
Recall: Z-0810-2021
·
Reported January 20, 2021
Enforcement
- Recall Number
- Z-0810-2021
- Event ID
- 87002
- Classification
- Class II
- Status
- Terminated
- Product Type
- Devices
- Firm
- Bioventus, LLC
- Voluntary / Mandated
- Voluntary: Firm initiated
- Initial Notification
- Letter
- Report Date
- January 20, 2021
- Initiation Date
- December 17, 2020
- Classification Date
- January 9, 2021
- Termination Date
- August 7, 2024
- Address
- 1900 Charles Bryan Rd Ste 275, N/A, Cordova, TN, 38016-5285, United States
Description
EXOGEN Ultrasound Coupling Gel
Reason
Product may contain white particulates that are microbial in nature.
Code Info
UDI: M937710344001. Part #71034475, Lot # 190235, 200207; Part # 71034694, Lot # 190235, 190263, 200218, 200228; Part # 71034695, Lot # 190235, 200207; Part # 81079892, Lot # 190204, 190211, 190213, 190226, 190228, 190250, 190251, 190252, 200212, 200215, 200227, 200229, 200240; Part # 81087015, Lot # 190215, 190230, 190235T, 200201, 200203, 200212T, 200215T, 200228T, 200240T
Distribution
United States (Nationwide), Australia, Austria, Belgium, Canada, Cyprus, Denmark, France, Germany, Hong Kong, Ireland, Italy, Japan, Netherlands, Norway, Poland, South Africa, Spain, Sweden, Switzerland, United Kingdom
Quantity
115,584 units