Recall Z-0399-2014 ยท JXG Shunt, Central Nervous System And Components
Medtronic Neurosurgery
Medtronic Strata II Shunt Assembly Kit, Small, Catalog No. 27848. Strata II Shunt Assemblies are designed to provide continued cerebrospinal fluid (CSF) flow from the ventricles of the brain into the right atrium of the heart of the peritoneal cavity.
| Date | Nov 26, 2013 (initiated Nov 18, 2013) |
| Status | Terminated |
| Reason | 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. |
| Root cause | 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 | 5 units |
| 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. |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
| K042465 | PS MEDICAL STRATA II VALVE Medtronic Neurosurgery, Oct 19, 2004 |