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U.S. Department of Health and Human Services

Class 2 Device Recall MaxGuard Extension Set with Injection Site and 0.2 micron filter

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 Class 2 Device Recall MaxGuard Extension Set with Injection Site and 0.2 micron filtersee related information
Date Initiated by FirmFebruary 20, 2017
Date PostedFebruary 28, 2017
Recall Status1 Terminated 3 on November 17, 2017
Recall NumberZ-1464-2017
Recall Event ID 76439
510(K)NumberK051499 
Product Classification Set, administration, intravascular - Product Code FPA
ProductMaxGuard Extension Set with Injection Site and 0.2 micron filter, Model No. ME3305
Code Information Lot No. 16016790
FEI Number 2016493
Recalling Firm/
Manufacturer		 CareFusion 303, Inc.
10020 Pacific Mesa Blvd
San Diego CA 92121-4386
Manufacturer Reason
for Recall		CareFusion is recalling the MaxGuard Extension Set with Injection Site and 0.2 micron filter because of reports of separation and/or leakages between the Y-connector and tubing.
FDA Determined
Cause 2		Process control
ActionAn Urgent Medical Device Recall Notification letter will be sent to customers on February 20, 2017 to inform them that CareFusion is recalling the MaxGuard Extension Set with Injection Site and 0.2 micron filter model number ME3305 Lot Number 16016790. Customers are informed that CareFusion has received reports of separation and/or leakages between theY-connector and tubing. Customers are informed that leakages from an extension set can cause delay of infusion, interruption of infusion, exposure to medication or hazardous infusates, or underinfusion. The letter informs the customers of the actions to be taken and for recall related questions to contact CareFusion Support Center at (888) 562-6018. Customers with adverse event reports are instructed to contact customer advocacy at (888) 812-3266.
Quantity in Commerce1,200 units
DistributionUS Distribution including MA and MD
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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