Z-0502-2015Class II

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

Name: Z-0502-2015 The Dual Switch Valve is used for fluid drainage from the ventricles into the peritoneum, in cases of...
Creator: Aesculap, Inc.
Published: 2014-10-24
License: https://open.fda.gov/license/

Aesculap Inc / initiated 2014-10-24 / Terminated / root cause: labeling and UDI

FDA source

Aesculap, Inc. began a recall of The Dual Switch Valve is used for fluid drainage from the ventricles into the peritoneum, in cases of hydrocephalus on 2014-10-24. FDA classified it as Class II and gives the reason as "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...". As of 2026-09-10, the recall status on record is Terminated, and MDM tags the root cause as labeling and UDI.

Recall record

Recall number: Z-0502-2015
Classification: Class II
Status: Terminated
Initiated: 2014-10-24
Posted: 2014-12-03
Terminated: 2015-05-20
Recalling firm: Aesculap Inc
Product: The Dual Switch Valve is used for fluid drainage from the ventricles into the peritoneum, in cases of hydrocephalus.
Product code: JXG Shunt, Central Nervous System And Components
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.
Root cause tag: labeling and UDI
FDA root cause: Labeling mix-ups
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.
Quantity in commerce: 1
Distribution: US Distribution in Kansas only.
Product codes and lots: Item Number FV129 Lot Number 4506244166 Serial Number A10150

Enforcement reports

One row per recalled product line

FDA enforcement reports joined to recall event Z-0502-2015
Recall number	Class	Status	Voluntary or mandated	Report date	Classified
Z-0502-2015	Class II	Terminated	Voluntary: Firm initiated	2014-12-10	2014-12-03

Product code JXG

K011030Class IIAesculap -Miethke Shunt SystemAesculap, Inc. / cleared 2002-03-01

MDM coverage of this record lists here, newest first.

About this record

Sourced from the FDA device recall database and the FDA enforcement reports, both ingested from openFDA. The recall record supplies the product, the reason and the product code; the enforcement report supplies the classification. The two datasets are exported by FDA on different days, and the date above is the older of the two, so nothing on this page is newer than it says.

MDM adds the root cause tag, derived from FDA’s own root cause text, and the cross-links to the product code, the clearances named on the record and MDM coverage. Where a recall has not been joined to an enforcement report, no classification is shown.

Data as of 2026-10-14, the FDA export date for this dataset. Page last changed 2026-09-05. View this recall on fda.gov (opens on fda.gov)