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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 Recall
83 Miniflex with accesory crate
see related information
Date Posted May 04, 2007
Recall Status1 Terminated on November 05, 2007
Recall Number Z-0770-2007
Recall Event ID 37702
Premarket Notification
510(K) Number
K061430 
Product Classification Accessories, Cleaning, For 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, Pennsylvania 18974-1449
Consumer Instructions Contact the recalling firm for information
For Additional Information Contact Frank Weber
215-364-1477
Manufacturer Reason
for Recall
The device was marketed without a 510k
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 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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