Recall Z-0814-2015 ยท JXG Shunt, Central Nervous System And Components
Aesculap, Inc.
Aesculap Miethke Shunt System, miniNAV Valve: The Miethke Shunt System is intended to shunt cerebrospinal fluid (CSF) from the lateral ventricles of the brain into the peritoneum.
| Date | Dec 16, 2014 (initiated Nov 11, 2014) |
| Status | Terminated |
| Reason | Aesculap Inc. (AIC (USA)) initiated a recall of Miethke Shunt System accessories due to missing patients' labels for the miniNAV (FV660T). There are no patient injuries resulting from this issue. |
| Root cause | Labeling Change Control |
| Action | An important correction & removal notification, dated November 11, 2014, was sent to consignees that identified the product, problem, and action to be taken. Consignees were asked to complete the distribution inventory sheet and return it. Aesculap sales representatives would be coordinating pick up of affected devices. |
| Quantity | 4 |
| Distribution | Distributed in OK, and WI. |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
| K110206 | AESCULAP- MEITHKE SHUNT SYSTEM Aesculap, Inc., Oct 27, 2011 |