| | Class 2 Device Recall |  |
| Date Initiated by Firm | July 05, 2005 |
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| Date Posted | August 10, 2005 |
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| Recall Status1 |
Terminated 3 on June 26, 2008 |
| Recall Number | Z-1110-05 |
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| Recall Event ID |
32595 |
| 510(K)Number | K990333 |
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| 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 |
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Manufacturer Reason
for Recall | Cracked hubs/handles and/or improper peeling of the sheath during use. |
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FDA Determined
Cause 2 | Other |
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| Action | Firm sent recall letters by Fedex on July 5, 2005 to all customers. |
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| Quantity in Commerce | 366 |
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| Distribution | Nationwide and to Canada, Australia, India, France, Italy, Netherlands, Portugal, South Africa, Spain, Switzerland, Turkey, United Kingdom. |
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| 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 = GWG
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