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U.S. Department of Health and Human Services

Class 2 Device Recall LifePort

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 Class 2 Device Recall LifePortsee related information
Date Initiated by FirmSeptember 27, 2010
Date PostedNovember 17, 2010
Recall Status1 Terminated 3 on June 21, 2011
Recall NumberZ-0405-2011
Recall Event ID 56876
510(K)NumberK905839 K905840 K905845 K911355 K915273 
Product Classification Pump, infusion - Product Code FRN
ProductLifePort, AngioDynamics, Inc., One Horizon Way, Manchester, GA 31816.
Code Information Catalogue Number: LPS5057, LPS5555, LPS5513, LPS5013, LPS7015, LPS7013, LPS7523, LPS7515, LPS7513, LPS7255 and LPS7113.
Recalling Firm/
Manufacturer
Angiodynamics, INC
1 Horizon Way
Manchester GA 31816-1749
For Additional Information ContactDavid Derrick
706-846-3126 Ext. 3114
Manufacturer Reason
for Recall
Labeling Error; The labeling for the specific products incorrectly identified that the packaged device kit contains a Lifeguard Safety Infusion Set.
FDA Determined
Cause 2
Other
ActionAngioDynamics issued a Notification of Medical Device Correction letter dated September 27, 2010 to customers. The notification served to make the customer aware of the mislabeling. Customers were instructed not to return the affected products. Customers can contact AngioDynamics at 1 800 772-6446 about this correction.
Quantity in Commercesee product one.
DistributionNationwide Distribution : Throughout the US.
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 = FRN
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