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U.S. Department of Health and Human Services

Class 2 Device Recall MaxGuard Extension Set, Model No. ME2064, MP9009C, MP9209, MP9254C

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  Class 2 Device Recall MaxGuard Extension Set, Model No. ME2064, MP9009C, MP9209, MP9254C see related information
Date Initiated by Firm February 20, 2017
Date Posted February 28, 2017
Recall Status1 Terminated 3 on October 29, 2018
Recall Number Z-1482-2017
Recall Event ID 76440
510(K)Number K051499  
Product Classification Set, administration, intravascular - Product Code FPA
Product MaxGuard Extension Set, Model No. ME2064, MP9009C, MP9209, MP9254C
The MaxGuard extension sets are used to administer fluids from a container to a patient s vascular system through a needle or catheter inserted into the patient s artery or vein. The extension sets may incorporate components that aid in the prevention of accidental needle sticks. The set s components are commonly found on intravascular administration sets and extension sets
Code Information Lot No. 15045419 15075822 15086644 16036290 16056204 16075270 15086404 16067461 16046571 16045810
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 due to reports of leaks occurring with the 0.2 micron filter.
FDA Determined
Cause 2		 Under Investigation by firm
Action CareFusion sent an Urgent Medical Device Recall Notification letter dated February 2017 to all affected customers inform them that CareFusion is recalling the MaxGuard Extension Set model codes ME20164, MP9009-C, MP9209, MP9254-C with multiple lot numbers. CareFusion has received reports of leaks occurring with the 0.2 micron filter. Customers were informed that leakages on an extension can cause delay of infusion, interruption of infusion, exposure to medication or hazardous infusates, underinfusion or air in line. Customers were instructed to discontinue use of the affected product and contact CareFusion for a replacement lot. 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. Customers were also instructed to immediately complete and return to CareFusion the enclosed, pre-addressed and postage paid, Recall Response Card.
Quantity in Commerce 12,850 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 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 = MEDEGEN MEDICAL MANUFACTURING SERVICES
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