FDA Medical Device Recalls (openFDA)
B. Braun Medical, Inc.: D-Stat Dry Hemostatic Bandage. The product is an adhesive bandage.
- Recall number
- Z-0003-06
- Recalling firm
- B. Braun Medical, Inc.
- Product
- D-Stat Dry Hemostatic Bandage. The product is an adhesive bandage.
- Status
- Terminated
- Initiated
- 2005-09-15
- Posted
- 2005-10-04
- Terminated
- 2006-03-23
- 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.
- Lot, serial or model codes
- Lot numbers 301323A and 301393
- 510(k) numbers
- ["K030836"]
- PMA numbers
- not on file
- Product code
- FRO
- Firm FEI
- 2523676
- Firm city
- Allentown
- Firm state
- PA
- Firm country
- not on file
Where this comes from
- Register
- FDA Medical Device Recalls (openFDA)
- Publisher
- U.S. Food and Drug Administration (openFDA)
- File
- device-recall-0001-of-0001.json.zip
- sha256
- b87518bfe2e8
- Size
- 288210821 bytes
- Published
- 2026-09-28
- Read
- 2026-09-29T08:25:23.626Z
- Source file
- Source file retained · verify
- Refresh due
- 2026-10-06
Unless otherwise noted, the content, data, documentation, code, and related materials on openFDA is public domain and made available with a Creative Commons CC0 1.0 Universal dedication.
Cite as
FDA Medical Device Recalls (openFDA) (U.S. Food and Drug Administration (openFDA)), device-recall-0001-of-0001.json.zip, sha256 b87518bfe2e8, published 2026-09-28