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Affected lots were manufactured with B/V Filter incorrectly attached to the wrong port (patient port instead of the exhalation port). If not noticed prior to patient use, there would be interruption or delay in patient resuscitation, which may lead to life threatening consequences, including hypoxia, hypercapnia, organ failure, and death.
It is possible that a package labelled as an 11.5 mm implant may contain a 13 mm implant instead.
Product may have an off color affecting perfomance