Recall Z-0814-2015— Aesculap, Inc.
Class III · Terminated
Class III FDA medical device recall by Aesculap, Inc., initiated 2014-11-11, terminated 2015-06-09. It names one FDA 510(k) clearance: K110206. Product: 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.. Reason: 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..
- Recalling firm
- Aesculap, Inc.
- Classification
- Class III
- Status
- Terminated
- Initiated
- 2014-11-11
- Terminated
- 2015-06-09
- Firm location
- Center Valley, PA, United States
510(k) clearances named in this recall
1 on FDA's recordK-numbers as listed on FDA's Recall Enterprise System record for this event (openFDA device/recall k_numbers). The recall may also cover devices cleared under other submissions not named here.
Product description
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.
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.
Data sourced from openFDA. This site is unofficial and independent of the FDA.