PlainRecalls
FDA Devices Moderate Class II Terminated

The Dual Switch Valve is used for fluid drainage from the ventricles into the peritoneum, in cases of hydrocephalus.

Reported: December 10, 2014 Initiated: October 24, 2014 #Z-0502-2015

Product Description

The Dual Switch Valve is used for fluid drainage from the ventricles into the peritoneum, in cases of hydrocephalus.

Reason for Recall

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.

Details

Recalling Firm
Aesculap, Inc.
Units Affected
1
Distribution
US Distribution in Kansas only.
Location
Center Valley, PA

Frequently Asked Questions

What product was recalled?
The Dual Switch Valve is used for fluid drainage from the ventricles into the peritoneum, in cases of hydrocephalus.. Recalled by Aesculap, Inc.. Units affected: 1.
Why was this product recalled?
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.
Which agency issued this recall?
This recall was issued by the FDA Devices on December 10, 2014. Severity: Moderate. Recall number: Z-0502-2015.