Company: CareFusion 303 Inc.
Date of Enforcement Report 10/52016
Class lI:
PRODUCT
Alaris Syringe Module Model 8110 with software version 9.15 The Alaris Syringe Pump module is part of the Alaris System. The syringe pump delivers fluids in a manner similar to current syringe pumps on the market. Up to four Alaris Syringe pump modules can be connected to the Alaris PC unit which is the central programming, monitoring and power supply component for the Alaris System. The syringe pump uses standard, single-use administration sets and syringes with luer-lock connectors.
Recall Number Z-2879-2016
REASON
A software anomaly with the Alaris Syringe module software version 9.15 may cause an infusion to unexpectedly stop when the Syringe module is transitioning from one rate to another.
RECALLING FIRM/MANUFACTURER
CareFusion 303, Inc., San Diego, CA on 9/32016. Voluntary: Firm Initiated recall is ongoing.
VOLUME OF PRODUCT IN COMMERCE
12.000 units
DISTRIBUTION
Nationwide, Canada, Australia and United Arab Emirates and Canada
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