Recall Z-0502-2015 ยท JXG Shunt, Central Nervous System And Components
Aesculap, Inc.
The Dual Switch Valve is used for fluid drainage from the ventricles into the peritoneum, in cases of hydrocephalus.
| Date | Dec 3, 2014 (initiated Oct 24, 2014) |
| Status | Terminated |
| Reason | Aesculap Inc. (AIC (USA)) initiated a recall of Miethke Shunt System, Dual Switch Valve, due to incorrect product labeling on three units. The incorrect product labeling was the wrong expiration date, 2024-09, on the inner labeling of the sterile bag. However, the expiration date on the outer box was correct. No patient injuries were reported as a result of this issue. |
| Root cause | Labeling mix-ups |
| Action | An important correction & removal notification letter, dated October 24, 2014, was sent to the sole consignee who received the affected device. The letter identified the product, problem, and action to be taken. |
| Quantity | 1 |
| Distribution | US Distribution in Kansas only. |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
| K011030 | AESCULAP -MIETHKE SHUNT SYSTEM Aesculap, Inc., Mar 1, 2002 |