Recall Z-1012-2015— Aesculap, Inc.

Name: FDA recall Z-1012-2015
Creator: U.S. Food and Drug Administration
Published: 2014-12-17

Class II · Terminated

Class II FDA medical device recall by Aesculap, Inc., initiated 2014-12-17, terminated 2016-12-13. It names one FDA 510(k) clearance: K120559. 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.. Reason: 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)..

Recalling firm: Aesculap, Inc.
Classification: Class II
Status: Terminated
Initiated: 2014-12-17
Terminated: 2016-12-13
Firm location: Center Valley, PA, United States

510(k) clearances named in this recall

1 on FDA's record

K120559 — AESCULAP-MEITHKE PROSA ADJUSTABLE SHUNT SYSTEMAesculap, Inc.·cleared 2012-05-24

K-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

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.

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).

Data sourced from openFDA. This site is unofficial and independent of the FDA.