Date Initiated by Firm | February 11, 2008 |
Date Posted | March 07, 2008 |
Recall Status1 |
Terminated 3 on September 03, 2009 |
Recall Number | Z-1182-2008 |
Recall Event ID |
46877 |
510(K)Number | K983017 |
Product Classification |
Endoscope Washer-Disinfector - Product Code KOG
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Product | System 83 Plus Washer-Disinfector, Endoscope use, DOS based system, Custom Ultrasonics Inc., Buckingham, PA |
Code Information |
All Serial Numbers |
Recalling Firm/ Manufacturer |
Custom Ultrasonics, Inc. 144 Railroad Dr Ivyland PA 18974-1449
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For Additional Information Contact | Bernd D. Ascher 215-364-1477 |
Manufacturer Reason for Recall | Inadvertent selection of the "wash" cycle |
FDA Determined Cause 2 | Labeling design |
Action | The recalling firm issued a Product Correction letter dated 2/11/08 to its customers informing them of the problem and the correction choices. The letter states that a key cover is available to reduce the error in the future and will be provided to each users upon return of the recall letter notification questionnaire. |
Quantity in Commerce | 3,190 units |
Distribution | Worldwide; USA medical facilities and physicians and Canada |
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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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510(K) Database | 510(K)s with Product Code = KOG
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