Health Canada — Medical Devices · Canada · 2020-05-29 · Type III
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Reported risk: The affected lots may be packaged in syringes which include an incorrect bung attached to the plunger. The specified bung is made of a silicone-based material, whereas the incorrect bung is made of a latex-free isoprene rubber material. After prolonged storage and exposure to contained solutions, the rubber bung may degrade due to chemical interaction with the bleach solution. When extruded, affected solutions may appear discolored (yellow/gray/black), or may contain small particulate matter. Affected material may contain percentages of sodium hypochlorite lower than those communicated on the labeling.
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