Health Canada — Medical Devices · Canada · 2021-09-10 · Type II
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Reported risk: During the testing process, a breach was confirmed in the Sterile barrier via Micro-hole testing, resulting in the possibility of non-sterile product conditions. The microscopic defects in the Mylar are 6420 70055003 h965700550031 sc 3w hp fm off nb - pg 0000007025, 0000012635, 0000016518, 5653288, 5658901, 5662967 6420 70055008 h965700550081 sc 3w hp ra/lt off nb - pg 0000007081, 0000014807, 5653287, 5656299 6420 70055009 h965700550091 sc 3w hp ra off nb - pg 0000003281, 0000003284, 0000007024, 0000007600, 0000007601, 0000009626, 0000009627, 0000010746, 0000012300, 0000012301, 0000012302, 0000014982, 0000015022, 0000016270, 0000016520, 5653286, 5657315, 5658895, 5658897, 5659900, 5659903, 5659905 6420 70055017 h965700550171 sc 1w hp fm tee nb - pg 0000007147, 0000010747, 0000015023, 56619973 Medline Canada 5150 Spectrum Way, Suite 300 Mississauga, ON I4W 5G2 Too small to be detected visually with the naked eye, therefore we cannot depend on users to determine whether a unit can be used.
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