FDA Medical Device Recalls (openFDA)
International Technidyne Corp: Tenderlett Adult Lancet, sterile, single use. Red trigger color with incision depth/length of 1.75mm/0.94mm. Manual surgical instrument for general use.
- Recall number
- Z-0673-06
- Recalling firm
- International Technidyne Corp
- 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.
- Status
- Terminated
- Initiated
- 2006-01-23
- Posted
- 2006-03-23
- Terminated
- 2006-06-30
- Reason
- Some packages contained a pin-hole defect that permitted the transmission of dye through the primary packaging. This is a sterile product.
- 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
- 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.
- Lot, serial or model codes
- Catalog No. TL100A and TL100I: NL512; NL513; NL514; NL515; NL516; NL517; NL518; NL520; NL524; NL525; NL526; NL527; NN521; NP501; NP502; NP503; NP504.
- 510(k) numbers
- ["K923302"]
- PMA numbers
- not on file
- Product code
- FMK
- Firm FEI
- 2250033
- Firm city
- Edison
- Firm state
- NJ
- Firm country
- not on file
Where this comes from
- Register
- FDA Medical Device Recalls (openFDA)
- Publisher
- U.S. Food and Drug Administration (openFDA)
- File
- device-recall-0001-of-0001.json.zip
- sha256
- b87518bfe2e8
- Size
- 288210821 bytes
- Published
- 2026-09-28
- Read
- 2026-09-29T08:25:23.626Z
- Source file
- Source file retained · verify
- Refresh due
- 2026-10-06
Unless otherwise noted, the content, data, documentation, code, and related materials on openFDA is public domain and made available with a Creative Commons CC0 1.0 Universal dedication.
Cite as
FDA Medical Device Recalls (openFDA) (U.S. Food and Drug Administration (openFDA)), device-recall-0001-of-0001.json.zip, sha256 b87518bfe2e8, published 2026-09-28