The Dual Switch Valve is used for fluid drainage from the ventricles into the peritoneum, in cases of hydrocephalus.
FDA device recall Z-0502-2015 · posted 2014-12-03 · Terminated
Recall details
- Recalling firm
- Aesculap, Inc.
- 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.
- Action taken
- 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
- Status
- Terminated
- Product code
- JXG
- Quantity affected
- 1
- Distribution
- US Distribution in Kansas only.
- Date initiated
- 2014-10-24
- Date posted
- 2014-12-03
- Date terminated
- 2015-05-20
- Location
- Center Valley, PA
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Related 510(k) clearances
| Record | Firm | Date |
|---|---|---|
| AESCULAP -MIETHKE SHUNT SYSTEM (K011030) | Aesculap, Inc. | 2002-03-01 |