RecallDepth

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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