Recall Z-0502-2015— Aesculap, Inc.

Name: FDA recall Z-0502-2015
Creator: U.S. Food and Drug Administration
Published: 2014-10-24

Class II · Terminated

Class II FDA medical device recall by Aesculap, Inc., initiated 2014-10-24, terminated 2015-05-20. It names one FDA 510(k) clearance: K011030. Product: The Dual Switch Valve is used for fluid drainage from the ventricles into the peritoneum, in cases of hydrocephalus.. Reason: Aesculap Inc. (AIC (USA)) initiated a recall of Miethke Shunt System, Dual Switch Valve, due to incorrect product labeling on three units. The incorrect product labeling was the wrong expiration date, 2024-09, on the inner labeling of the sterile bag. However, the expiration date on the outer box was correct. No patient injuries were reported as a result of this issue..

Recalling firm: Aesculap, Inc.
Classification: Class II
Status: Terminated
Initiated: 2014-10-24
Terminated: 2015-05-20
Firm location: Center Valley, PA, United States

510(k) clearances named in this recall

1 on FDA's record

K011030 — AESCULAP -MIETHKE SHUNT SYSTEMAesculap, Inc.·cleared 2002-03-01

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

The Dual Switch Valve is used for fluid drainage from the ventricles into the peritoneum, in cases of hydrocephalus.

Reason for recall

Aesculap Inc. (AIC (USA)) initiated a recall of Miethke Shunt System, Dual Switch Valve, due to incorrect product labeling on three units. The incorrect product labeling was the wrong expiration date, 2024-09, on the inner labeling of the sterile bag. However, the expiration date on the outer box was correct. No patient injuries were reported as a result of this issue.

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