Class 2 Device Recall DStat Dry Hemostatic Bandage

• Date Initiated by Firm: September 15, 2005
• Date Posted: October 04, 2005
• Recall Status: Terminated on March 23, 2006
• Recall Number: Z-0003-06
• Recall Event ID: 33598
• 510(K)Number: K030836
• Product Classification: Dressing, Wound, Drug - Product Code FRO
• Product: D-Stat Dry Hemostatic Bandage. The product is an adhesive bandage.
• Code Information: Lot numbers 301323A and 301393
• FEI Number: 2523676
• Recalling Firm/ Manufacturer: B. Braun Medical, Inc.; 901 Marcon Blvd; Allentown PA 18109-9512
• For Additional Information Contact: Kikoo Tewjani; 610-266-0500 Ext. 2254
• Manufacturer Reason for Recall: package sealing defect - product may not be sterile
• FDA Determined 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 in Commerce: 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.
• Total Product Life Cycle: TPLC Device Report

¹ A record in this database is created when a firm initiates a correction or removal action. The record is updated if the FDA identifies a violation and classifies the action as a recall, and it is updated for a final time when the recall is terminated. Learn more about medical device recalls.
² Per FDA policy, recall cause determinations are subject to modification up to the point of termination of the recall.
³ For details about termination of a recall see Code of Federal Regulations (CFR) Title 21 §7.55.

• 510(K) Database: 510(K)s with Product Code = FRO