Miethke Shunt System accessories Product Usage: - The Miethke Shunt System is intended to shut cerebrospinal fluid from
FDA device recall Z-1012-2015 · posted 2015-01-26 · Terminated
Recall details
- Recalling firm
- Aesculap, Inc.
- Reason for recall
- Some Miethke Shunt System accessories may have an incorrect MR safety symbol on the shelf box label. The label should have NO symbol but instead is marked with the MR conditional symbol. The product is MR unsafe. This information is only required to be in the Instructions for Use (IFU).
- Action taken
- Aesculap sent an Important Correction and Removal and Field Safety Notification letter, dated December 17, 2014, to all affected customers. The letter identiifed the affected product, problem, and actions to be taken. Customers were requested to remove from inventory and contact Aesculap regarding return of the affected devices and acknowledgement form.
- Root cause
- Labeling False and Misleading
- Status
- Terminated
- Product code
- JXG
- Quantity affected
- 772
- Distribution
- Worldwide Distribution - US Nationwide
- Date initiated
- 2014-12-17
- Date posted
- 2015-01-26
- Date terminated
- 2016-12-13
- Location
- Center Valley, PA
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Related 510(k) clearances
| Record | Firm | Date |
|---|---|---|
| AESCULAP-MEITHKE PROSA ADJUSTABLE SHUNT SYSTEM (K120559) | Aesculap, Inc. | 2012-05-24 |