CSF-Unitized Shunt, Contoured Regular, Low Pressure, Catalog No. 46022; CSF-Unitized Shunt, Contoured Regular, Medium Pr
FDA device recall Z-0397-2014 · posted 2013-11-26 · Terminated
Recall details
- Recalling firm
- Medtronic Neurosurgery
- 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.
- Action taken
- 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.
- Root cause
- Other
- Status
- Terminated
- Product code
- JXG
- Quantity affected
- 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 Emirate
- Date initiated
- 2013-11-18
- Date posted
- 2013-11-26
- Date terminated
- 2014-02-06
- Location
- Goleta, CA
Monitor recalls programmatically
Recalls and clearances share one API, with change alerts when new recalls post.
Related 510(k) clearances
| Record | Firm | Date |
|---|---|---|
| P-S MEDICAL CSF-FLOW CONTROL VALVE- (K841442) | P-S Medical | 1984-04-19 |
| CSF-CARDIAC/PERITONEAL CATHETER (K792005) | Pudenz-Schulte Medical Research Corp. | 1980-01-16 |
| CSF-VENTRICULAR CATHETER, STANDARD DES (K792007) | Pudenz-Schulte Medical Research Corp. | 1980-01-16 |