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Class 2 Device Recall Penumbra Neuron Delivery Catheter 053 |
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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
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Product Classification |
Percutaneous catheter - Product Code DQY
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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
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For Additional Information Contact |
510-618-3223
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Manufacturer Reason for Recall |
Misbranding--Some products may be identified with the wrong ID band content 'Neuron 6F 070' instead of 'Neuron 6F delivery'
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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
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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.
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510(K) Database |
510(K)s with Product Code = DQY and Original Applicant = PENUMBRA, INC.
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