(b)(4).Conclusion: to date, the device has not been returned.If the product is returned for evaluation, any further info derived from the evaluation will be submitted in a supplemental 3500a form.The actual device batch number associated with this event is not known.Two possible batch numbers are reported as follows: batch gjb938, batch gln535.In addition, a review of the batch manufacturing records for the possible batch number gjb938 was conducted and the batch met all finished goods release criteria.
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