Company Name – Silfradent Srl (Italy, manufacturer of instruments for dental laboratories)
Subject: CGMP/QSR/Medical Devices/Adulterated
Violations included in the letter:
Alaris System Infusion Pumps by Becton Dickinson (BD) CareFusion 303 – Class I Recall
For modules with software version 9.33 or earlier, the following issues apply:
For modules with software version 12.1.0, the following issues apply:
These errors can lead to delay in infusion, interruption of infusion, slower than expected delivery of medication (under-infusion), and faster than expected delivery of medication (over-infusion).
There have been serious adverse health events with each of these errors. There are 55 reported injuries and one death.
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