E-Z-EM brand, Basic biopsy tray, catalog no. 4125.
FDA device recall Z-1523-05 · posted 2005-09-08 · Terminated
Recall details
- Recalling firm
- North Coast Medi-Tek Inc
- Reason for recall
- Product contains the incorrect lot number.
- Action taken
- The recalling firm sent revised correct labels, containing the correct lot number, to the consignee which were affixed to the box containing the device.
- Root cause
- Other
- Status
- Terminated
- Product code
- LRO
- Quantity affected
- 70 cases, each case containing 5 devices.
- Distribution
- The product was distributed to one domestic consignee: E-Z-EM, 717 Main Street, Westbury, NY 11590.
- Date initiated
- 2004-06-23
- Date posted
- 2005-09-08
- Date terminated
- 2007-02-21
- Location
- Mentor, OH
Monitor recalls programmatically
Recalls and clearances share one API, with change alerts when new recalls post.
Related 510(k) clearances
| Record | Firm | Date |
|---|---|---|
| BIOPSY TRAY I & II (K854095) | North Coast Medi-Tek | 1985-11-25 |