Aesculap Miethke Shunt System, miniNAV Valve: The Miethke Shunt System is intended to shunt cerebrospinal fluid (CSF) fr
FDA device recall Z-0814-2015 · posted 2014-12-16 · Terminated
Recall details
- Recalling firm
- Aesculap, Inc.
- Reason for recall
- Aesculap Inc. (AIC (USA)) initiated a recall of Miethke Shunt System accessories due to missing patients' labels for the miniNAV (FV660T). There are no patient injuries resulting from this issue.
- Action taken
- An important correction & removal notification, dated November 11, 2014, was sent to consignees that identified the product, problem, and action to be taken. Consignees were asked to complete the distribution inventory sheet and return it. Aesculap sales representatives would be coordinating pick up of affected devices.
- Root cause
- Labeling Change Control
- Status
- Terminated
- Product code
- JXG
- Quantity affected
- 4
- Distribution
- Distributed in OK, and WI.
- Date initiated
- 2014-11-11
- Date posted
- 2014-12-16
- Date terminated
- 2015-06-09
- Location
- Center Valley, PA
Monitor recalls programmatically
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Related 510(k) clearances
| Record | Firm | Date |
|---|---|---|
| AESCULAP- MEITHKE SHUNT SYSTEM (K110206) | Aesculap, Inc. | 2011-10-27 |