A record in this database is created when a firm initiates a correction or removal action. The record is updated if the FDA identifies a violation and classifies the action as a recall, and it is updated for a final time when the recall is terminated. Learn more about medical device recalls.
Per FDA policy, recall cause determinations are subject to modification up to the point of termination of the recall.
The manufacturer has initiated the recall and not all products have been corrected or removed. This record will be updated as the status changes.
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