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Recall Observatory FDA recall evidence

Device product

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

Z-0502-2015

October 24, 2014

Class II

Product summary

Firm
Aesculap, Inc.
Event
Event 69600
Status
Terminated
Classification
Class II
Quantity
1
Official record key
device-enforcement:Z-0502-2015

Official wording

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.

Code information: Item Number FV129 Lot Number 4506244166 Serial Number A10150

Distribution pattern: US Distribution in Kansas only.

Derived failure modes

  • Labeling or packaging

    reason.labeling_packaging · v1.0.0

    labeling on three units. The incorrect