Hem-o-LokSMX Legating Clip, REF 544220, Lot 988384, Non-absorbable Polymer Ligation Clips, Sterile EO, Weck Closure Syst
FDA device recall Z-0547-04 · posted 2004-02-25 · Terminated
Recall details
- Recalling firm
- Weck
- Reason for recall
- Malformation of the Hem-o-lok SMX clip.
- Action taken
- Consignees were notified by letter via Federal Express (Domestic consignees), Email (International and Weck Sales Representatives), and Fax (Weck Sales Representatives) beginning 01/23/2004.
- Root cause
- Other
- Status
- Terminated
- Product code
- FZP
- Quantity affected
- 70 sales units
- Distribution
- Distributors and hospitals in AL, CA, FL, MA, MD, MI, NC, NY, OH, OR, PA, SC, TX, Korea and France
- Date initiated
- 2004-01-23
- Date posted
- 2004-02-25
- Date terminated
- 2004-05-11
- Location
- Research Triangle Park, NC
Monitor recalls programmatically
Recalls and clearances share one API, with change alerts when new recalls post.
Related 510(k) clearances
| Record | Firm | Date |
|---|---|---|
| HEM-O-LOK MODEL NUMBERS 523900, 523970 (K982941) | Weck Closure Systems | 1998-11-19 |