Recall Z-1012-2015 ยท JXG Shunt, Central Nervous System And Components
Aesculap, Inc.
Miethke Shunt System accessories Product Usage: - The Miethke Shunt System is intended to shut cerebrospinal fluid from the lateral ventricles of the brain into the peritoneum.
| Date | Jan 26, 2015 (initiated Dec 17, 2014) |
| Status | Terminated |
| Reason | Some Miethke Shunt System accessories may have an incorrect MR safety symbol on the shelf box label. The label should have NO symbol but instead is marked with the MR conditional symbol. The product is MR unsafe. This information is only required to be in the Instructions for Use (IFU). |
| Root cause | Labeling False and Misleading |
| Action | Aesculap sent an Important Correction and Removal and Field Safety Notification letter, dated December 17, 2014, to all affected customers. The letter identiifed the affected product, problem, and actions to be taken. Customers were requested to remove from inventory and contact Aesculap regarding return of the affected devices and acknowledgement form. |
| Quantity | 772 |
| Distribution | Worldwide Distribution - US Nationwide |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
| K120559 | AESCULAP-MEITHKE PROSA ADJUSTABLE SHUNT SYSTEM Aesculap, Inc., May 24, 2012 |