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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 Lancetsee related information
Date Initiated by FirmJanuary 23, 2006
Date PostedMarch 23, 2006
Recall Status1 Terminated 3 on June 30, 2006
Recall NumberZ-0673-06
Recall Event ID 34461
510(K)NumberK923302 
Product Classification Single Use Only Blood Lancet With An Integral Sharps Injury Prevention Feature - Product Code FMK
ProductTenderlett 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 ContactMr. 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
ActionRecall 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 Commerce1616 BOXES of 100 pouches
DistributionProduct 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 CycleTPLC 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) Database510(K)s with Product Code = FMK
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