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U.S. Department of Health and Human Services

Class 1 Device Recall Alaris Pump Module 8100

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  Class 1 Device Recall Alaris Pump Module 8100 see related information
Date Initiated by Firm December 02, 2016
Date Posted January 18, 2017
Recall Status1 Open3, Classified
Recall Number Z-0950-2017
Recall Event ID 75466
510(K)Number K950419  
Product Classification Pump, infusion - Product Code FRN
Product Alaris Pump Module, Model No. 8100 and AIL sensor kits, P/N 147083-102 and P/N 49000221.

The Alaris Pump module is a large volume infusion pump offered under the Alaris System. The Alaris Pump module will deliver medication and fluids using IV administration sets for continuous or intermittent delivery through clinically acceptable routes of administration such as intravenous or epidural
Code Information All products manufactured or serviced in the time period October 2011 through June 2015.
Recalling Firm/
Manufacturer
CareFusion 303, Inc.
10020 Pacific Mesa Blvd
San Diego CA 92121-4386
For Additional Information Contact
858-617-2000
Manufacturer Reason
for Recall
During an infusion, a false Air-in-Line (AIL) alarm would cause the infusion to be interrupted.
FDA Determined
Cause 2
Component change control
Action Carefusion (BD) sent a Medical Device Safety Notification letter dated December 2, 2016, to all affected customers. The letter informed customers that BD has identified an issue with the Alaris Pump module. The letter informs the customers that the firm has received reports of Air-In-Line (AIL) alarms that have occurred when no air is observed in the line. Customers were informed of the issue and of the potential risk involved. The letter informs the customers of the actions for users and additional actions for biomedical engineering. Customers with questions regarding recall related questions were instructed to contact BD Support Center at (888) 562-6018, 7-4pm PT, M-F or email supportcenter@carefusion.com. Customers with adverse event reports are instructed to contact Customer Advocacy at (888) 812-3266, 24 hrs/day, 7days/wk. or email customerfeedback@carefusion.com. For questions regarding this recall call 858-617-2000.
Quantity in Commerce 382,635 units
Distribution Nationwide Distribution
Total Product Life Cycle TPLC 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 The manufacturer has initiated the recall and not all products have been corrected or removed. This record will be updated as the status changes.
510(K) Database 510(K)s with Product Code = FRN and Original Applicant = IMED CORP.
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