TriActiv System Procedure Kit. Balloon Protected Flush Extraction System 340 cm (for embolism protection). The kit inclu
FDA device recall Z-1220-06 · posted 2006-07-12 · Terminated
Recall details
- Recalling firm
- Kensey Nash Corp
- Reason for recall
- volume control knob not able to go up to larger diameters
- Action taken
- A letter was issued to the sales representative that have customers which received affected product, 5/24/2006. Sales representatives visited their sites within 3 days to determine if the affected product was still in inventory. If the product was still in inventory the sales representative provided the trained TriActiv System user(s) a Technical Bulletin that instructed the users how to correct the knob position.
- Root cause
- Other
- Status
- Terminated
- Product code
- NFA
- Quantity affected
- 10 kits
- Distribution
- Nationwide. The products are shipped to hospitals in AL, DE, Fl, IL, IN, MI, PA, SC, TN and TX.
- Date initiated
- 2006-05-24
- Date posted
- 2006-07-12
- Date terminated
- 2006-07-11
- Location
- Exton, PA
Monitor recalls programmatically
Recalls and clearances share one API, with change alerts when new recalls post.
Related 510(k) clearances
| Record | Firm | Date |
|---|---|---|
| TRIACTIV SYSTEM (K042040) | Kensey Nash Corp. | 2005-03-23 |