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U.S. Department of Health and Human Services

Class 3 Device Recall

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  Class 3 Device Recall see related information
Date Initiated by Firm February 28, 2005
Date Posted March 12, 2005
Recall Status1 Terminated 3 on July 12, 2005
Recall Number Z-0615-05
Recall Event ID 31283
510(K)Number k010341  
Product Classification Endoscope, Neurological - Product Code GWG
Product MurphyScope, Bayonet, Malleable, Catalog # 2121-157
Code Information Lot A52300
Recalling Firm/
Manufacturer		 Medtronic Neurosurgery
125 Cremona Dr
Goleta CA 93117-5503
For Additional Information Contact Jeffery Henderson
800-826-5603
Manufacturer Reason
for Recall		 Products are mislabeled.
FDA Determined
Cause 2		 Process control
Action Recall letters were sent to customers on 2/28/05 requesting return for replacement.
Quantity in Commerce 2
Distribution NJ and India.
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 = GWG and Original Applicant = MEDTRONIC PS MEDICAL
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