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U.S. Department of Health and Human Services

Class 2 Device Recall

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 Class 2 Device Recallsee related information
Date Initiated by FirmFebruary 15, 2016
Create DateMarch 17, 2016
Recall Status1 Terminated 3 on October 24, 2016
Recall NumberZ-1179-2016
Recall Event ID 73238
510(K)NumberK944320 
Product Classification Set, administration, intravascular - Product Code FPA
ProductAlaris Pump VersaSafe Infusion Set, Model No. 2122-0007
Code Information Lot No. 13085603
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		CareFusion is recalling the Alaris VersaSafe Infusion Set because of separation and/or leakages at the VersaSafe split septum port and tubing may lead to leakage of the administration set.
FDA Determined
Cause 2		Other
ActionA customer notification letter dated 2/15/16 will be sent to customers to inform them that CareFusion is recalling the Alaris VersaSafe Infusion set number 2122-0007, Lot number 13085603. The letter informs the customers that Separation or leakage at the VersaSafe split septum port and tubing may lead to leakage of the administration set. The separation and leakage may occur during infusion. The letter informs customers of the potential risk and actions to be taken. Customers with recall related equations 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, customerfeedback@carefusion.com, 24 hrs/day, 7 days/wk. Customers are instructed to complete and return the enclosed mandatory customer response card to acknowledge the receipt of the customer communication.
Quantity in Commerce5,760 units
DistributionMichigan
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 = FPA
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