EXOGEN Ultrasound Coupling Gel
FDA Recall #Z-0810-2021 — Class II — December 17, 2020
Product Description
EXOGEN Ultrasound Coupling Gel
Reason for Recall
Product may contain white particulates that are microbial in nature.
Recalling Firm
Bioventus, LLC — Cordova, TN
Classification
Class II — May cause temporary or medically reversible adverse health consequences.
Product Type
Devices
Product Quantity
115,584 units
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
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
Status
Terminated
Voluntary / Mandated
Voluntary: Firm initiated