Medical Device
Manufacturing
THE TRADE PAPER OF THE FACTORY FLOOR
Z-0144-2008

Storz Equipment, Fluid Management Stand, for Fluid Management Systems, Product Number 26601EQ-KT

Karl Storz Endoscopy-America, Inc. / initiated 2007-08-17 / Terminated / root cause: design

Karl Storz Endoscopy America Inc began a recall of Storz Equipment, Fluid Management Stand, for Fluid Management Systems, Product Number 26601EQ-KT on . The reason FDA records is "Outflow Difference: The accuracy of the Equimat displayed value could be influenced by external factors of the cart/stand and may result in a fluctuating or inaccurate reading". As of , the recall status on record is Terminated, and MDM tags the root cause as design.

Recall record

Recall number
Z-0144-2008
Status
Terminated
Initiated
Posted
Terminated
Recalling firm
Karl Storz Endoscopy-America, Inc.
Product
Storz Equipment, Fluid Management Stand, for Fluid Management Systems, Product Number 26601EQ-KT
Product code
HIG Insufflator, Hysteroscopic
Reason for recall
Outflow Difference: The accuracy of the Equimat displayed value could be influenced by external factors of the cart/stand and may result in a fluctuating or inaccurate reading.
Root cause tag
design
FDA root cause
Device Design
Action
All affected customers were notified via a Customer Letter issued on September 10, 2007 via FedEx overnight mail. The letter describes the problem with the device and the health hazard risk, and provides instructions for users to return the old stand and make arrangements for replacement stands.
Quantity in commerce
287
Distribution
Nationwide
Product codes and lots
Product Number 26601EQ-KT (device has no lot or serial numbers)