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U.S. Department of Health and Human Services

Class 2 Device Recall Alaris Syringe Module Model 8110

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 Class 2 Device Recall Alaris Syringe Module Model 8110see related information
Date Initiated by FirmAugust 08, 2016
Create DateSeptember 23, 2016
Recall Status1 Terminated 3 on October 26, 2018
Recall NumberZ-2879-2016
Recall Event ID 74508
510(K)NumberK023264 
Product Classification Pump, infusion - Product Code FRN
ProductAlaris 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.
Code Information Software version 9.15
Recalling Firm/
Manufacturer		 CareFusion 303, Inc.
10020 Pacific Mesa Blvd
San Diego CA 92121-4386
For Additional Information ContactMichelle Badal
858-617-5925
Manufacturer Reason
for Recall		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.
FDA Determined
Cause 2		Software design
ActionThe firm, BD, sent an "Urgent: Medical Device Recall Notification" letter dated 8/8/16 to customers to inform them that BD has identified a software anomaly associated with the Alaris Syringe module software version 9.15. The letter describes the product, problem and actions to be taken. The customers were instructed to follow the instructions and promptly complete and return the Customer Response Card to expedite the corrective action process. Customers with recall related questions are instructed to contact the BD Support Center at (888) 562-6018. Customers with adverse event reports are instructed to contact customer advocacy at (888) 812-3266. Customers with technical questions regarding the Alaris System are instructed to contact Technical Support at (888) 812-3229.
Quantity in Commerce12,000 units
DistributionWorldwide Distribution: US(nationwide) and countries of: Canada, Australia and United Arab Emirates.
Total Product Life CycleTPLC Device Report
1 A record in this database is created when a firm initiates a correction or removal action. The record is updated if the FDA identifies a violation and classifies the action as a recall, and it is updated for a final time when the recall is terminated. Learn more about medical device recalls.
2 Per FDA policy, recall cause determinations are subject to modification up to the point of termination of the recall.
3 For details about termination of a recall see Code of Federal Regulations (CFR) Title 21 §7.55.
510(K) Database510(K)s with Product Code = FRN
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