The Dual Switch Valve is used for fluid drainage from the ventricles… — Class II medical device recall Z-0502-2015
Terminated recall by Aesculap, Inc., reported 2014-12-10, distributed in KS. Aesculap Inc. (AIC (USA)) initiated a recall of Miethke Shunt System, Dual Switch Valve, due to incorrect prod
| Recall number | Z-0502-2015 |
|---|---|
| Product type | Medical device |
| Classification | Class II |
| Status | Terminated |
| Voluntary or mandated | Voluntary |
| Recalling firm | Aesculap, Inc., Center Valley, PA, United States |
| Recall initiated | 2014-10-24 |
| Classified | 2014-12-03 |
| Reported by FDA | 2014-12-10 |
| Terminated | 2015-05-20 |
| Distributed | KS |
| Quantity | 1 |
| Reason classes | labeling, sterility |
| Lot numbers | 4506244166 |
| Serial numbers | A10150 |
| Model numbers | FV129 |
Product
The Dual Switch Valve is used for fluid drainage from the ventricles into the peritoneum, in cases of hydrocephalus.
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.
Machine access
This record, with every extracted code, the verbatim FDA record and provenance, is available from the recall API: GET https://api.data.aroqon.com/v1/recalls/Z-0502-2015. Look up any UPC, UDI, NDC or lot with /v1/recalls/lookup?code=…. API docs · free and paid keys.
Source: U.S. Food and Drug Administration enforcement report via openFDA (CC0). Structured by Data Foundry (recall-structuring@2); last changed 2026-09-26. Not affiliated with or endorsed by FDA. Not medical or legal advice.