Recall Z-0144-2008
Karl Storz Endoscopy America Inc · initiated August 17, 2007
Product
Storz Equipment, Fluid Management Stand, for Fluid Management Systems, Product Number 26601EQ-KT
Codes / lots: Product Number 26601EQ-KT (device has no lot or serial numbers)
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.
FDA-determined cause: Device Design
Action taken
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.
Details
- Recall number
- Z-0144-2008
- Initiated
- August 17, 2007
- Posted by FDA
- November 7, 2007
- Terminated
- February 29, 2012
- Product code
- HIG – Insufflator, Hysteroscopic
- Quantity
- 287
- Distribution
- Nationwide
- Recalling firm
- Karl Storz Endoscopy America Inc, Culver City, CA