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U.S. Department of Health and Human Services

Class 2 Device Recall 83 Miniflex with accesory crate

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  Class 2 Device Recall 83 Miniflex with accesory crate see related information
Date Initiated by Firm December 12, 2005
Date Posted May 04, 2007
Recall Status1 Terminated 3 on February 20, 2013
Recall Number Z-0770-2007
Recall Event ID 37702
510(K)Number K061430  
Product Classification Accessory for cleaning endoscope - Product Code FEB
Product 83 plus Mini-flex with accessory crate, Custom Ultrasonics, Inc.
Code Information Serial numbers: 051305-J, 061705-E, 061605-F, and 061705-G.
Recalling Firm/
Manufacturer		 Custom Ultrasonics, Inc.
144 Railroad Dr
Ivyland PA 18974-1449
For Additional Information Contact Frank Weber
215-364-1477
Manufacturer Reason
for Recall		 The device was marketed without a 510k
FDA Determined
Cause 2		 PMA
Action On 12/12/05, the recalling firm telephoned their sales representatives to inform them of the problem. Letter were hand delivered to the hospitals by the sales representatives.
Quantity in Commerce 4 units
Distribution Worldwide-The device was shipped to medical facilities in CA, GA, VA. and the UK.
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.
510(K) Database 510(K)s with Product Code = FEB and Original Applicant = CUSTOM ULTRASONICS
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