Health Canada — Medical Devices · Canada · 2018-08-31 · Type II
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Reported risk: The packaging defectiveness related to the catalogue and lot numbers listed in Attachment 2 is due to the integrity of the fill port tube seal of the media container which was compromised during the manufacture of the product. This may cause media to leak out of the primary sterile packaging into the outer non-sterile dust cover packaging. This issue was first identified on April 19th, 2018.
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