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)
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