Tenderlett Adult Lancet, sterile, single use. Red trigger color with incision depth/length of 1.75mm/0.94mm. Manual surgical instrument for general use.
FDA Recall Z-0673-06 · Posted 2006-03-23
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Recalling FirmInternational Technidyne Corp
Recall StatusTerminated
Product CodeFMK
Date Initiated2006-01-23
Date Terminated2006-06-30
Product Quantity1616 BOXES of 100 pouches
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.
Firm 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.
Root Cause
Other
Distribution Pattern
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.
Related FDA 510(k) Records
Devices referenced by this recall via K-numbers.
Official Source
View FDA Recall →Source: FDA Enforcement Report / Recall database. Always confirm against the official FDA record.
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