D-Stat Dry Hemostatic Bandage. The product is an adhesive bandage.
FDA device recall Z-0003-06 · posted 2005-10-04 · Terminated
Recall details
- Recalling firm
- B. Braun Medical, Inc.
- Reason for recall
- package sealing defect - product may not be sterile
- Action taken
- The recalling firm issued a recall letter dated 9/15/05 informing their accounts of the problem and the need to return the product.
- Root cause
- Other
- Status
- Terminated
- Product code
- FRO
- Quantity affected
- 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.
- Date initiated
- 2005-09-15
- Date posted
- 2005-10-04
- Date terminated
- 2006-03-23
- Location
- Allentown, PA
Monitor recalls programmatically
Recalls and clearances share one API, with change alerts when new recalls post.
Related 510(k) clearances
| Record | Firm | Date |
|---|---|---|
| D-STAT-DRY HEMOSTATIC BANDAGE; D-STAT RADIAL HEMOSTATIC BANDAGE (K030836) | Vascular Solutions, Inc. | 2003-09-17 |