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Class 3 Device Recall |
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Date Initiated by Firm |
September 15, 2003 |
Date Posted |
July 20, 2004 |
Recall Status1 |
Terminated 3 on October 21, 2003 |
Recall Number |
Z-0050-04 |
Recall Event ID |
27299 |
Product Classification |
Endoscope, Neurological - Product Code GWG
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Product |
Channel Neuroendoscope, Standard Resolution, 13 cm, Catalog No. 2232-003. |
Code Information |
A22148 |
Recalling Firm/ Manufacturer |
Medtronic Neurosurgery 125 Cremona Drive Goleta CA 93117
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For Additional Information Contact |
Jeffrey Henderson 805-826-5603 Ext. 1770
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Manufacturer Reason for Recall |
Size mix-up. 13 cm product may be labeled as 21.6 mm and visaversa.
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FDA Determined Cause 2 |
Labeling mix-ups |
Action |
Firm sales representatives will contact customers and hand deliver the recall notice. |
Quantity in Commerce |
10 |
Distribution |
TN, CO, GA and Japan |
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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