Z-0810-2021 Class II Terminated
FDA device recall Z-0810-2021 was initiated by Bioventus, LLC on December 17, 2020 and is designated Class II. Reason for recall: Product may contain white particulates that are microbial in nature. The recall status is terminated (terminated August 7, 2024). Affected quantity: 115,584 units.
Recall Details
- Product Type
- Devices
- Report Date
- January 20, 2021
- Initiation Date
- December 17, 2020
- Termination Date
- August 7, 2024
- Voluntary/Mandated
- Voluntary: Firm initiated
- Product Quantity
- 115,584 units
Product Description
EXOGEN Ultrasound Coupling Gel
Reason for Recall
Product may contain white particulates that are microbial in nature.
Distribution Pattern
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
Code Information
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