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Page 11 of 11 SOP No.+ Version No. Supersedes: SOP No. Attachments: 1 (one page) Effective date:
Product Recall
8.
Attachment 1: Recall Decision Flow Chart Identification of a potential product non-compliance issue
no
yes Convene Recall Committee 1. Technical Assessment 2. Medical Assessment 3. Documents for Recall
no
Recall Decision
yes Implementation
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