The actual device was not available; however, photographs of the sample were provided for evaluation.The photographs were inspected and it was noted that a carton had two labels, one placed atop the other, with the bottom label showing through the top label.The reported condition was verified.The cause of the reported condition could not be determined.A nonconformance has been opened to address this issue.A batch review was conducted by the third party manufacturer and found one deviation noted during manufacture of the product.This deviation captured a request by the client (baxter) to relabel the product with a new label.Should additional relevant information become available, a supplemental report will be submitted.
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