The Dual Switch Valve is used for fluid drainage from the ventricles into the peritoneum, in cases of hydrocephalus.
This recall has been terminated (originally issued December 3, 2014).
- Company
- Aesculap Inc
- Recall Initiated
- October 24, 2014
- Posted
- December 3, 2014
- Terminated
- May 20, 2015
- Recall Number
- Z-0502-2015
- Quantity
- 1
- Firm Location
- Center Valley, PA
- Official Source
- View on FDA website ↗
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.
Distribution
US Distribution in Kansas only.
Lot / Code Info
Item Number FV129 Lot Number 4506244166 Serial Number A10150
Root Cause
Labeling mix-ups
Action Taken
An important correction & removal notification letter, dated October 24, 2014, was sent to the sole consignee who received the affected device. The letter identified the product, problem, and action to be taken.