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U.S. Department of Health and Human Services

Class 2 Device Recall Boston Scientific 1.0mm x 570 mm rigid pneumatic probe

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  Class 2 Device Recall Boston Scientific 1.0mm x 570 mm rigid pneumatic probe see related information
Date Initiated by Firm September 17, 2009
Date Posted November 11, 2009
Recall Status1 Terminated 3 on October 08, 2010
Recall Number Z-0175-2010
Recall Event ID 53582
510(K)Number K012445  
Product Classification Lithotriptor, electro-hydraulic - Product Code FFK
Product Boston Scientific 1.0mm x 570 mm rigid pneumatic probe for use only with Swiss LithoClast Select System model no. 840-300K, Swiss LithoClast Ultra System model nol 840-700K, or Swiss LithoClast Ultra Upgraded System model no. 840-701U, compatible with 330mm Ultrasound Probes (REF 840-714 and 840-715), Rx, sterile, no detectable latex, Packaged and Distributed by Boston Scientific Corporation, Natick, MA; REF/catalog no 840-733.
Code Information Lots 12723202, 12745667, 12767883, 12777930, 12782625, 12808559, 12813607, 12850772 and 12861508.
Recalling Firm/
Manufacturer		 Boston Scientific Corp
780 Brookside Dr
Spencer IN 47460-1080
For Additional Information Contact
866-868-4004
Manufacturer Reason
for Recall		 The label incorrectly reads "compatible with 330mm ultrasound probes (Ref 840-714 and 840-715)" instead of bearing the correct statement "compatible with 403mm ultrasound probes (Ref 840-716 and 840-7170."
FDA Determined
Cause 2		 Other
Action Consignees were notified by letter titled "Urgent Medical Device Recall-Immediate Action Required" dated 9/17/09 and instructed to cease using the product and to call the firm's customer service for return authorization. For additional information, call the firm at 866-868-4004.
Quantity in Commerce 173
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.
510(K) Database 510(K)s with Product Code = FFK and Original Applicant = ELECTRO MEDICAL SYSTEMS SA
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