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U.S. Department of Health and Human Services

Class 2 Device Recall Storz

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  Class 2 Device Recall Storz see related information
Date Initiated by Firm August 17, 2007
Date Posted November 07, 2007
Recall Status1 Terminated 3 on February 29, 2012
Recall Number Z-0144-2008
Recall Event ID 44957
Product Classification Fluid Management Stand - Product Code HIG
Product Storz Equipment, Fluid Management Stand, for Fluid Management Systems, Product Number 26601EQ-KT
Code Information Product Number 26601EQ-KT (device has no lot or serial numbers)
Recalling Firm/
Manufacturer		 Karl Storz Endoscopy America Inc
600 Corporate Pointe
Culver City CA 90230-7600
For Additional Information Contact Emily Cuadros
800-421-0837 Ext. 4289
Manufacturer 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 2		 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
Total Product Life Cycle TPLC Device Report
1 A record in this database is created when a firm initiates a correction or removal action. The record is updated if the FDA identifies a violation and classifies the action as a recall, and it is updated for a final time when the recall is terminated. Learn more about medical device recalls.
2 Per FDA policy, recall cause determinations are subject to modification up to the point of termination of the recall.
3 For details about termination of a recall see Code of Federal Regulations (CFR) Title 21 §7.55.
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