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