FDA Medical Device Recalls (openFDA)
Aesculap, Inc.: The Dual Switch Valve is used for fluid drainage from the ventricles into the peritoneum, in cases of hydrocephalus.
- Recall number
- Z-0502-2015
- Recalling firm
- Aesculap, Inc.
- Product
- The Dual Switch Valve is used for fluid drainage from the ventricles into the peritoneum, in cases of hydrocephalus.
- Status
- Terminated
- Initiated
- 2014-10-24
- Posted
- 2014-12-03
- Terminated
- 2015-05-20
- 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.
- 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
- 1
- Distribution
- US Distribution in Kansas only.
- Lot, serial or model codes
- Item Number FV129 Lot Number 4506244166 Serial Number A10150
- 510(k) numbers
- ["K011030"]
- PMA numbers
- not on file
- Product code
- JXG
- Firm FEI
- 2916714
- Firm city
- Center Valley
- Firm state
- PA
- Firm country
- not on file
Where this comes from
- Register
- FDA Medical Device Recalls (openFDA)
- Publisher
- U.S. Food and Drug Administration (openFDA)
- File
- device-recall-0001-of-0001.json.zip
- sha256
- b87518bfe2e8
- Size
- 288210821 bytes
- Published
- 2026-09-28
- Read
- 2026-09-29T08:25:23.626Z
- Source file
- Source file retained · verify
- Refresh due
- 2026-10-06
Unless otherwise noted, the content, data, documentation, code, and related materials on openFDA is public domain and made available with a Creative Commons CC0 1.0 Universal dedication.
Cite as
FDA Medical Device Recalls (openFDA) (U.S. Food and Drug Administration (openFDA)), device-recall-0001-of-0001.json.zip, sha256 b87518bfe2e8, published 2026-09-28