The Dual Switch Valve is used for fluid drainage from the ventricles into the peritoneum, in cases of hydrocephalus.
FDA Recall Z-0502-2015 · Posted 2014-12-03
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Recalling FirmAesculap, Inc.
Recall StatusTerminated
Product CodeJXG
Date Initiated2014-10-24
Date Terminated2015-05-20
Product Quantity1
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.
Firm 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.
Root Cause
Labeling mix-ups
Distribution Pattern
US Distribution in Kansas only.
Related FDA 510(k) Records
Devices referenced by this recall via K-numbers.
Official Source
View FDA Recall →Source: FDA Enforcement Report / Recall database. Always confirm against the official FDA record.
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