Date Initiated by Firm | December 02, 2016 |
Date Posted | January 18, 2017 |
Recall Status1 |
Terminated 3 on July 24, 2018 |
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 |
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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.
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510(K) Database | 510(K)s with Product Code = FRN
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