Storz Equipment, Fluid Management Stand, for Fluid Management Systems, Product Number 26601EQ-KT
FDA device recall Z-0144-2008 · posted 2007-11-07 · Terminated
Recall details
- Recalling firm
- Karl Storz Endoscopy America Inc
- 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.
- 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.
- Root cause
- Device Design
- Status
- Terminated
- Product code
- HIG
- Quantity affected
- 287
- Distribution
- Nationwide
- Date initiated
- 2007-08-17
- Date posted
- 2007-11-07
- Date terminated
- 2012-02-29
- Location
- Culver City, CA
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