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U.S. Department of Health and Human Services

Class 2 Device Recall Blue Torch

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  Class 2 Device Recall Blue Torch see related information
Date Initiated by Firm July 10, 2003
Date Posted September 13, 2003
Recall Status1 Terminated 3 on October 22, 2003
Recall Number Z-1235-03
Recall Event ID 27068
510(K)Number k993436  k000507  
Product CaverMap Surgical Aid Disposable Kit with Focused Probe Tip, Sterile
Part Number: 8305
Code Information Lot Number: JCQ3141 EXpiration Date:May 2004
Recalling Firm/
Manufacturer		 Blue Torch Medical Technologies
200 Homer Avenue
Ashland Technology Center
Ashland MA 01721
For Additional Information Contact Frederick Tobia
617-618-5105
Manufacturer Reason
for Recall		 Product's sterility is compromised due to a failed sterility audit
FDA Determined
Cause 2		 Other
Action Blue TorchMedical notified 2 consignees by fax on 7/10/03, requesting return of unused inventory.
Quantity in Commerce 20 units
Distribution NY, TX
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 = and Original Applicant = UROMED CORP.
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