Device product
The Dual Switch Valve is used for fluid drainage from the ventricles into the peritoneum, in cases of hydrocephalus.
Z-0502-2015
Product summary
- Firm
- Aesculap, Inc.
- Event
- Event 69600
- Status
- Terminated
- Classification
- Class II
- Quantity
- 1
- Official record key
device-enforcement:Z-0502-2015
Official wording
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.
Code information: Item Number FV129 Lot Number 4506244166 Serial Number A10150
Distribution pattern: US Distribution in Kansas only.
Derived failure modes
-
Labeling or packaging
labeling on three units. The incorrect