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U.S. Department of Health and Human Services

Class 2 Device Recall Tenderlett Adult Lancet

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  Class 2 Device Recall Tenderlett Adult Lancet see related information
Date Initiated by Firm January 23, 2006
Date Posted March 23, 2006
Recall Status1 Terminated 3 on June 30, 2006
Recall Number Z-0673-06
Recall Event ID 34461
510(K)Number K923302  
Product Classification Single Use Only Blood Lancet With An Integral Sharps Injury Prevention Feature - Product Code FMK
Product Tenderlett Adult Lancet, sterile, single use. Red trigger color with incision depth/length of 1.75mm/0.94mm. Manual surgical instrument for general use.
Code Information Catalog No. TL100A and TL100I:  NL512; NL513; NL514; NL515; NL516; NL517; NL518; NL520; NL524; NL525; NL526; NL527; NN521; NP501; NP502; NP503; NP504.
Recalling Firm/
Manufacturer		 International Technidyne Corp
23 Nevsky St
Edison NJ 08820-2425
For Additional Information Contact Mr. David Gronostajski
732-548-5700 Ext. 265
Manufacturer Reason
for Recall		 Some packages contained a pin-hole defect that permitted the transmission of dye through the primary packaging. This is a sterile product.
FDA Determined
Cause 2		 Other
Action Recall letter was sent out 1/25/2006 via UPS tracking system per the distribution record addressees. With Cardinal Health, the letter was sent out to the firm''s corporate headquarters location.
Quantity in Commerce 1616 BOXES of 100 pouches
Distribution Product was distributed nationwide to medical supply distributors. The product was also shipped internationally to 3 countries: Canada, Czech Republic, and New Zealand. There are no Govt. accounts.
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 = FMK and Original Applicant = INTERNATIONAL TECHNIDYNE CORP.
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