Recall Z-1012-2015
Aesculap, Inc. · initiated December 17, 2014
Class II – products that might cause a temporary health problem or pose a slight threat of a serious nature
Product
Miethke Shunt System accessories Product Usage: - The Miethke Shunt System is intended to shut cerebrospinal fluid from the lateral ventricles of the brain into the peritoneum.
Codes / lots: material numbers: FV400T FV401T FV402T FV403T FV404T FV405T FV406T FV407T FV408T FV409T FV499T FV790T FV791T FV792T FV793T FV794T FV795T FV796T
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).
FDA-determined cause: Labeling False and Misleading
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.
Details
- Recall number
- Z-1012-2015
- Initiated
- December 17, 2014
- Posted by FDA
- January 26, 2015
- Terminated
- December 13, 2016
- Product code
- JXG – Shunt, Central Nervous System And Components
- Quantity
- 772
- Distribution
- Worldwide Distribution - US Nationwide
- Recalling firm
- Aesculap, Inc., Center Valley, PA