Recall Z-0673-06 ยท FMK Single Use Only Blood Lancet With An Integral Sharps Injury Prevention Feature
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.
| Date | Mar 23, 2006 (initiated Jan 23, 2006) |
| Status | Terminated |
| 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. |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
| K923302 | TENDERLETT FINGER International Technidyne Corp., Jan 22, 1993 |