Z-0673-06

Tenderlett Adult Lancet, sterile, single use. Red trigger color with incision depth/length of 1.75mm/0.94mm...

Name: Z-0673-06 Tenderlett Adult Lancet, sterile, single use. Red trigger color with incision depth/length of 1.75mm/0.94mm...
Creator: International Technidyne Corp
Published: 2006-01-23
License: https://open.fda.gov/license/

Accriva Diagnostics, Inc. / initiated 2006-01-23 / Terminated / root cause: packaging

FDA source

International Technidyne Corp began a recall of Tenderlett Adult Lancet, sterile, single use. Red trigger color with incision depth/length of 1.75mm/0.94mm. Manual surgical instrument for general use on 2006-01-23. The reason FDA records is "Some packages contained a pin-hole defect that permitted the transmission of dye through the primary packaging. This is a sterile product". As of 2026-09-10, the recall status on record is Terminated, and MDM tags the root cause as packaging.

Recall record

Recall number: Z-0673-06
Status: Terminated
Initiated: 2006-01-23
Posted: 2006-03-23
Terminated: 2006-06-30
Recalling firm: Accriva Diagnostics, Inc.
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.
Product code: FMK Single Use Only Blood Lancet With An Integral Sharps Injury Prevention Feature
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.
Root cause tag: packaging
FDA root cause: 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.
Product codes and lots: Catalog No. TL100A and TL100I: NL512; NL513; NL514; NL515; NL516; NL517; NL518; NL520; NL524; NL525; NL526; NL527; NN521; NP501; NP502; NP503; NP504.

Product code FMK

K923302Class IITenderlett FingerInternational Technidyne Corp. / cleared 1993-01-22

MDM coverage of this record lists here, newest first.

About this record

Sourced from the FDA device recall database and the FDA enforcement reports, both ingested from openFDA. The recall record supplies the product, the reason and the product code; the enforcement report supplies the classification. The two datasets are exported by FDA on different days, and the date above is the older of the two, so nothing on this page is newer than it says.

MDM adds the root cause tag, derived from FDA’s own root cause text, and the cross-links to the product code, the clearances named on the record and MDM coverage. Where a recall has not been joined to an enforcement report, no classification is shown.

Data as of 2026-09-30, the FDA export date for this dataset. Page last changed 2026-09-05. View this recall on fda.gov (opens on fda.gov)