FDA Recall
Terminated
The Dual Switch Valve is used for fluid drainage from the ventricles into the peritoneum, in cases of hydrocephalus.
Recall: Z-0502-2015
·
Initiated October 24, 2014
Recall
- Recall Number
- Z-0502-2015
- Event Number
- 69600
- Firm
- Aesculap, Inc.
- FEI Number
- 2916714
- Product Code
- JXG
- Status
- Terminated
- Root Cause
- Labeling mix-ups
- Initiated
- October 24, 2014
- Posted
- December 3, 2014
- Terminated
- May 20, 2015
- Address
- 3773 Corporate Pkwy, Center Valley, PA, 18034-8217
Description
The Dual Switch Valve is used for fluid drainage from the ventricles into the peritoneum, in cases of hydrocephalus.
Reason
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.
Action
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.
Distribution
US Distribution in Kansas only.
Quantity
1