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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 Device Recall Penumbra Neuron Delivery Catheter 053 see related information
Date Initiated by Firm July 01, 2009
Date Posted September 24, 2009
Recall Status1 Terminated 3 on November 30, 2010
Recall Number Z-2313-2009
Recall Event ID 52989
510(K)Number K070970  
Product Classification Percutaneous catheter - 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 CA 94502-6541
For Additional Information Contact
510-618-3223
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		 Mixed-up of materials/components
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 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 = DQY and Original Applicant = PENUMBRA, INC.
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