FDA Recall
Terminated
D-Stat Dry Hemostatic Bandage. The product is an adhesive bandage.
Recall: Z-0003-06
·
Initiated September 15, 2005
Recall
- Recall Number
- Z-0003-06
- Event Number
- 33598
- Firm
- B. Braun Medical, Inc.
- FEI Number
- 2523676
- Product Code
- FRO
- Status
- Terminated
- Root Cause
- Other
- Initiated
- September 15, 2005
- Posted
- October 4, 2005
- Terminated
- March 23, 2006
- Address
- 901 Marcon Blvd, Allentown, PA, 18109-9512
Description
D-Stat Dry Hemostatic Bandage. The product is an adhesive bandage.
Reason
package sealing defect - product may not be sterile
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.
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.
Quantity
60 units