Bioventus, LLC Recall 87002
Description: EXOGEN Ultrasound Coupling Gel
Bioventus, LLC Recall 87002 Information
| Status | Ongoing |
| Mandated? | Voluntary: Firm initiated |
| Recall Number | Z-0810-2021 |
| Event ID | 87002 |
| Event Description | EXOGEN Ultrasound Coupling Gel |
| Product Type | Devices |
| 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 |
| Recall Reason | Product may contain white particulates that are microbial in nature. |
| Device Classification | 20210120 |
| Device 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 |
| Center Classification Date | 20210109 |
| Recall Initiation Date | 20201217 |
| Recalling Firm | Bioventus, LLC |
| Initial Notification | Letter |
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