Device product
EXOGEN Ultrasound Coupling Gel
Z-0810-2021
Product summary
- Firm
- Bioventus, LLC
- Event
- Event 87002
- Status
- Terminated
- Classification
- Class II
- Quantity
- 115,584 units
- Official record key
device-enforcement:Z-0810-2021
Official wording
Reason: Product may contain white particulates that are microbial in nature.
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
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
Derived failure modes
-
Foreign material or chemical contamination
particulates