Recall Z-1523-05 ยท LRO General Surgery Tray
North Coast Medi-Tek Inc
E-Z-EM brand, Basic biopsy tray, catalog no. 4125.
| Date | Sep 8, 2005 (initiated Jun 23, 2004) |
| Status | Terminated |
| Reason | Product contains the incorrect lot number. |
| Root cause | Other |
| Action | The recalling firm sent revised correct labels, containing the correct lot number, to the consignee which were affixed to the box containing the device. |
| Quantity | 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. |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
| K854095 | BIOPSY TRAY I & II North Coast Medi-Tek, Nov 25, 1985 |