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.
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