Tenderlett Adult Lancet, sterile, single use. Red trigger color with incision depth/length of 1.75mm/0.94mm. Manual surg
FDA device recall Z-0673-06 · posted 2006-03-23 · Terminated
Recall details
- Recalling firm
- International Technidyne Corp
- 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.
- Action taken
- 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
- Status
- Terminated
- Product code
- FMK
- Quantity affected
- 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.
- Date initiated
- 2006-01-23
- Date posted
- 2006-03-23
- Date terminated
- 2006-06-30
- Location
- Edison, NJ
Monitor recalls programmatically
Recalls and clearances share one API, with change alerts when new recalls post.
Related 510(k) clearances
| Record | Firm | Date |
|---|---|---|
| TENDERLETT FINGER (K923302) | International Technidyne Corp. | 1993-01-22 |