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U.S. Department of Health and Human Services

Class 2 Device Recall Alaris Pump SmartSite Infusion Set

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  Class 2 Device Recall Alaris Pump SmartSite Infusion Set see related information
Date Initiated by Firm November 05, 2015
Date Posted December 17, 2015
Recall Status1 Terminated 3 on March 01, 2017
Recall Number Z-0445-2016
Recall Event ID 72583
510(K)Number K944320  
Product Classification Set, administration, intravascular - Product Code FPA
Product Alaris Pump SmartSite Infusion Set, Model No. 2420-0500.

Used to administer fluid and medications through a needle or catheter inserted into the patient's artery or vein.
Code Information 15086733 15086937 15095168 15095332 15095772 15096137 15096516 15086756 15095022 15095212 15095333 15095773 15096183 15096627 15086832 15095045 15095213 15095334 15095842 15096184 15096628 15086833 15095088 15095214 15095347 15095843 15096222 15096629 15086864 15095103 15095254 15095490 15095844 15096291 15096703 15086865 15095128 15095255 15095504 15095936 15096292 15096704 15086910 15095136 15095274 15095505 15096020 15096412 15096722 15086911 15095137 15095275 15095561 15096021 15096413 15096723 15086912 15095166 15095289 15095644 15096050 15096443 15086936 15095167 15095327 15095645 15096125 15096515
Recalling Firm/
Manufacturer		 CareFusion 303, Inc.
10020 Pacific Mesa Blvd
San Diego CA 92121-4386
For Additional Information Contact Chuck Donlon
858-617-2000
Manufacturer Reason
for Recall		 CareFusion is recalling the Alaris Pump Module SmartSite Infusion Set because the disconnection and leakage may occur during infusion.
FDA Determined
Cause 2		 Other
Action An urgent recall letter dated 11/6/15 will be sent to all customers who purchased the Alaris Pump Module SmartSite Infusion Set because CareFusion has received reports of breakage of the spin collar on the male luer. The letter informs the customers of the problems identified and the actions to be taken. Customers are instructed to complete and return to CareFusion the enclosed recall response card. Customers with questions related to recall are instructed to contact CareFusion Support Center at (888) 562-6018, 7am-4pm PST. Customers with adverse event reports are instructed to contact customer advocacy at (888) 812-3266, customer feedback@carefusion, 24 hrs/day, 7days/wk.
Quantity in Commerce 1,445,180 units
Distribution Worldwide Distribution-US (nationwide) and the countries of Canada, Australia, and New Zealand.
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 For details about termination of a recall see Code of Federal Regulations (CFR) Title 21 §7.55.
510(K) Database 510(K)s with Product Code = FPA and Original Applicant = IMED CORP.
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