Recall Z-0544-04 ยท NAC Dressing, Wound, Hydrophilic
DeRoyal Surgical Tray
Multidex Powder, Maltodextrin Wound Dressing, Catalog Numbers: 46-701, 46-702, 46-703, 46-704, 46-702-1, 46-703-1, 46-704-1; Type of Packaging: Tubes, dispenser box
| Date | Feb 24, 2004 (initiated Jan 19, 2004) |
| Status | Terminated |
| Reason | Hydrophilic powder wound dressing, sterilized at a dosage which subsequently failed a sterility audit, was distributed. |
| Root cause | Other |
| Action | The firm notified their consignees via letter sent UPS 2nd day air on 01/19/2004 requesting return of the product. |
| Quantity | 2,495 units |
| Distribution | Nationwide and Europe |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
| K945000 | MULTIDEX HYDROPHILIC WOUND DRESSING Lange Medical Products, Inc., Nov 17, 1994 |