The Dual Switch Valve is used for fluid drainage from recall: Labeling Error
The Dual Switch Valve is used for fluid drainage from the ventricles into the peritoneum, in cases of hydrocephalus.
Why was The Dual Switch Valve is used for fluid drainage from 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.
What should I do if I have this product?
Review the official FDA enforcement record for current instructions.
What to do with a recalled product: refunds, receipts, safe disposal and how to report a problem.
Is my product affected?
Compare the item in your hand with every identifier below from the official FDA record. Only products that match the listed product and lot, UPC or model codes are part of this recall.
Which lot codes, UPCs or models are affected?
Item Number FV129 Lot Number 4506244166 Serial Number A10150
- Product
- The Dual Switch Valve is used for fluid drainage from the ventricles into the peritoneum, in cases of hydrocephalus.
- Recalling firm
- Aesculap, Inc.
- Quantity
- 1
- Distribution
- US Distribution in Kansas only.
- Recall date
- December 10, 2014
- Classification
- Class II
- Status
- Terminated
- Agency
- FDA (device)