Aesculap Miethke Shunt System, miniNAV Valve: The Miethke Shunt System is intended to shunt cerebrospinal fluid (CSF) from the lateral ventricles of the brain into the peritoneum.
- Company
- Aesculap Inc
- Recall Initiated
- November 11, 2014
- Posted
- December 16, 2014
- Terminated
- June 9, 2015
- Recall Number
- Z-0814-2015
- Quantity
- 4
- Firm Location
- Center Valley, PA
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.
Distribution
Distributed in OK, and WI.
Lot / Code Info
Catalog No: FV660T Lot No: 4506022655
Root Cause
Labeling Change Control
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.
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