| Class 2 Device Recall CSFUnitized Shunt | |
Date Initiated by Firm | November 18, 2013 |
Date Posted | November 26, 2013 |
Recall Status1 |
Terminated 3 on February 06, 2014 |
Recall Number | Z-0397-2014 |
Recall Event ID |
66882 |
510(K)Number | K792005 K792007 K841442 |
Product Classification |
Shunt, central nervous system and components - Product Code JXG
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Product | CSF-Unitized Shunt, Contoured Regular, Low Pressure, Catalog No. 46022;
CSF-Unitized Shunt, Contoured Regular, Medium Pressure, Catalog No. 46024; CSF-Unitized Shunt, Contoured Regular, High Pressure,
Catalog No. 46026.
CSF-Unitized Shunt Kits are designed as integrated CSF-Flow Control Shunts for use in shunting cerebrospinal fluid from the lateral ventricle of the brain into the peritoneal cavity. |
Code Information |
Lot Numbers: Catalog No. 46022: D27162; D30984; D3461 0; D35834; D37761; D39054; D39539. Catalog No. 46024: D13944; D14093; D14217; D14216; D33526; D39540. Catalog No. 46026: D35572; D39583. |
Recalling Firm/ Manufacturer |
Medtronic Neurosurgery 125 Cremona Dr Goleta CA 93117-3083
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For Additional Information Contact | 805-571-8445 |
Manufacturer Reason for Recall | Medtronic Neurosurgery is recalling the CSF-Unitized Shunts, Delta Shunt Assembly Kit, and the Strata II Shunt Assembly Kit because they were found to have label discrepancies. |
FDA Determined Cause 2 | Other |
Action | Medtronic Neurosurgery sent an Urgent Medical Device Recall letter dated November 18, 2013, to all affected customers. The letter identified the product, the problem, and the action to be taken by the customer. Customers were advised to provide a copy of the letter to all those who need to be aware of the matter within their organization or to any organization where the potentially affected product may have been transferred. Customers with questions were instructed to call 805-571-8725. |
Quantity in Commerce | 288 units total (147 units in US) |
Distribution | Worldwide Distribution - USA (nationwide) and Internationally to US and worldwide: Austria, Belgium, Bosnia, Herzegovina, Canada, Croatia, Germany, Japan, Poland, Portugal, Taiwan, United Arab Emirates, United Kingdom. |
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 = JXG 510(K)s with Product Code = JXG
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