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U.S. Department of Health and Human Services

Class 2 Device Recall

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  Class 2 Device Recall see related information
Date Initiated by Firm July 05, 2005
Date Posted August 10, 2005
Recall Status1 Terminated 3 on June 26, 2008
Recall Number Z-1110-05
Recall Event ID 32595
510(K)Number k990333  
Product Classification Endoscope, Neurological - Product Code GWG
Product Medtronic Neurosurgery C/N 3805-014 Peelaway Introducer Sheath, Disposable 14 F
Code Information Lots: A46413, A6414, A48711, A49692, A53066, A53867, A55500, A55753, A57046, A58460, A60519, A61343, A67224.
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
Cracked hubs/handles and/or improper peeling of the sheath during use.
FDA Determined
Cause 2
Other
Action Firm sent recall letters by Fedex on July 5, 2005 to all customers.
Quantity in Commerce 366
Distribution Nationwide and to Canada, Australia, India, France, Italy, Netherlands, Portugal, South Africa, Spain, Switzerland, Turkey, United Kingdom.
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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