Recall Z-0003-06 ยท FRO Dressing, Wound, Drug
B. Braun Medical, Inc.
D-Stat Dry Hemostatic Bandage. The product is an adhesive bandage.
| Date | Oct 4, 2005 (initiated Sep 15, 2005) |
| Status | Terminated |
| Reason | package sealing defect - product may not be sterile |
| Root cause | Other |
| Action | The recalling firm issued a recall letter dated 9/15/05 informing their accounts of the problem and the need to return the product. |
| Quantity | 60 units |
| Distribution | The product was shipped to hospitals/medical facilities in AZ, CA, FL, GA, IL, MA, MN, MO, NY, NJ, OH, PA, TN, TX, and WI. |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
| K030836 | D-STAT-DRY HEMOSTATIC BANDAGE; D-STAT RADIAL HEMOSTATIC BANDAGE Vascular Solutions, Inc., Sep 17, 2003 |