Class 2 Device Recall 83 Miniflex with accesory crate

• Date Initiated by Firm: December 12, 2005
• Date Posted: May 04, 2007
• Recall Status: Terminated 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.
• FEI Number: 2523209
• 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: 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