Recall Z-0625-05 ยท ELW Material, Impression
Heraeus Kulzer Inc.
Heraeus Kulzer brand P2 Magnum 360 Trial Kit, Heavy + Light; catalog number 66009583.
| Date | Mar 15, 2005 (initiated Nov 1, 2003) |
| Status | Terminated |
| Reason | Packaging defects could result in improper mixing ratios and unusable impressions. |
| Root cause | Other |
| Action | Customers were notified via undated letter on or about November 1, 2003 and instructed to return product on hand.. |
| Quantity | 1183 bags. |
| Distribution | Nationwide. |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
| K030318 | P2 POLYETHER Heraeus Kulzer, Inc., Apr 3, 2003 |