EXOGEN Ultrasound Coupling Gel
This recall has been terminated (originally issued December 17, 2020).
- Company
- Bioventus, Llc
- Recall Initiated
- December 17, 2020
- Terminated
- August 7, 2024
- Recall Number
- Z-0810-2021
- Quantity
- 115,584 units
- Firm Location
- Cordova, TN
- Official Source
- View on FDA website ↗
Reason for Recall
Product may contain white particulates that are microbial in nature.
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
Lot / 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
Root Cause
Nonconforming Material/Component
Action Taken
Device Recall Notice 3010203571-12/14/20-001-R was sent to customers beginning 12/17/2020. Customers were instructed to dispose of the product and verify disposal lot and quantity.