FDA Device recall Z-0502-2015
The Dual Switch Valve is used for fluid drainage from the ventricles into the peritoneum, in cases of hydrocephalus
- FDA Device
- Class II
- terminated
- Published 2014-12-10
On 2014-12-10 the FDA classified a Class II recall of The Dual Switch Valve is used for fluid drainage from the ventricles into the peritoneum, in cases of hydrocephalus by Aesculap, citing 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 w….
Read the official FDA Device notice
| Agency | FDA Device |
|---|---|
| Recall number | Z-0502-2015 |
| Classification | Class II |
| Status | terminated |
| Initiated | 2014-10-24 |
| Published | 2014-12-10 |
| Last updated | 2026-09-13 11:53 UTC |
| Company | Aesculap |
| Distribution | KS |
Product
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.
Identifiers
| code_info | Item Number FV129 Lot Number 4506244166 Serial Number A10150 |
|---|
Status history
No status changes recorded since RecallRadar first saw this recall on 2026-09-13 11:53 UTC. Current status: terminated.
Other recalls by Aesculap
- Brand Name: AESCULAP Product Name: MINOP TROCAR 150MM 4 WKING CHANNEL6.0MM Model/Catalog Number: FF399R Software Version: N/A Product Descr…
FDA Device · Class II · 2026-03-11 · Aesculap - Brand Name: Aesculap Product Name: SEALING UNIT F/10/12MM TROCARS W.REDUCER Model/Catalog Number: EK083P Software Version: N/A Product Desc…
FDA Device · Class II · 2025-11-05 · Aesculap - Brand Name: AESCULAP Product Name: SEALING UNIT FOR 10/12MM TROCARS Model/Catalog Number: EK086P Software Version: N/A Product Description:…
FDA Device · Class II · 2025-11-05 · Aesculap - Brand Name: Aesculap Product Name: SEALING CAP FOR 10/12MM TROCARS Model/Catalog Number: EK085P Software Version: N/A Product Description:…
FDA Device · Class II · 2025-11-05 · Aesculap - Brand Name: AESCULAP Product Name: REDUCING CONVERTER 10/12MM TO 5MM Model/Catalog Number: EK087P Software Version: N/A Product Description…
FDA Device · Class II · 2025-11-05 · Aesculap
Source
Official record: https://api.fda.gov/device/enforcement.json?search=recall_number:%22Z-0502-2015%22
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