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U.S. Department of Health and Human Services

Class 2 Device Recall Penumbra Neuron Delivery Catheter 053

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 Class 2 Recall
Penumbra Neuron Delivery Catheter 053
see related information
Date Posted September 24, 2009
Recall Status1 Open
Recall Number Z-2313-2009
Recall Event ID 52989
Premarket Notification
510(K) Number
K070970 
Product Classification Catheter, Percutaneous - Product Code DQY
Product Penumbra Neuron Delivery Catheter 053, 115 cm/12 cm-- MP, manufactured by Penumbra Inc., Alameda, CA Percutaneous Catheter, indicated for the introduction of interventional devices into the peripheral, coronary and neuro vasculature.
Code Information Catalog number PND6F11512M, lot number F14751
Recalling Firm/
Manufacturer
Penumbra Inc.
1351 Harbor Bay Pkwy
Alameda, California 94502-6541
Manufacturer Reason
for Recall
Misbranding--Some products may be identified with the wrong ID band content 'Neuron 6F 070' instead of 'Neuron 6F delivery'
FDA Determined
Cause 2
COMPONENT CONTROLS (GMP - GOOD MANUFACTURING PRACTICE): Release of Mat./Comp. prior to Test Results
Action Firm initiated its recall on June 30, 2009. Consignees notified on July 6 and 7, with follow up contact on July 7, 2009. Contact Penumbra Inc. at 1.510.618.3223, if there are any questions.
Quantity in Commerce 37 units
Distribution CA, FL, NC, MI, MO, VA, AZ, CT, IA, NY, and CO, Foreign: Germany and Australia.
Total Product Life Cycle TPLC Device Report

 
1 For details about termination of a recall see Code of Federal Regulations (CFR) Title 21 §7.55
2 Per FDA policy, recall cause determinations are subject to modification up to the point of termination of the recall.
510(K) Database 510(K)s with Product Code = DQY and Original Applicant = PENUMBRA, INC.
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