FDA-Device2014-12-10Class II
The Dual Switch Valve is used for fluid drainage from the ventricles into the peritoneum, in cases of hydrocephalus.
Aesculap, Inc.
Hazard
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.
Sold states
US Distribution in Kansas only.
Affected count
1
Manufactured in
3773 Corporate Pkwy, N/A, Center Valley, PA, United States
Products
The Dual Switch Valve is used for fluid drainage from the ventricles into the peritoneum, in cases of hydrocephalus.
Official notice
https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-0502-2015Don't want to check this manually?
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