This event has been recorded in (b)(6).Defective units were returned to manufacturer and the presence of white powder on the container surface was confirmed.Three (3) units from the same manufacturing lot were retrieved from retained samples, and the presence of white powder was also observed.However, the batch record of the affected lot number was reviewed and no incidence similar to the one reported was detected in the controls done during the manufacturing process nor in the controls done before the product release.It seems that this powder might be originated by a migration of some of the plastic substances of the container's material, generating a thin layer on the container's surface, but no conclusion can be made yet.
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A white powdery film was identified on all the pumps opened for 2 boxes of dosi-fuser 250d2 lot 181171l.All cases/pumps were sequestered and returned to manufacturer.In addition, that same white substance was identified on 2 dosi-fuser 250d1 pumps, lot 181087l, that were returned to the manufacturer as well.This white powder is observed both in the inside and the outside of the transparent container.
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