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Aesculap, Inc. recalls The Dual Switch Valve is used for fluid drainage from the ventricles into the peritoneum, in cases of hydrocephalus.
Recalled December 10, 2014 · FDA recall Z-0502-2015 · Aesculap
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. · FDA Class II
Units
1
Sold at
US Distribution in Kansas only.
Description
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.
Product
The Dual Switch Valve is used for fluid drainage from the ventricles into the peritoneum, in cases of hydrocephalus.
Manufacturer(s)
Aesculap, Inc.
Source: U.S. Food and Drug Administration. Official recall notice on fda.gov →