Medical Device Recall: Z-0003-06

FDA Recalls dataset · Firm: B. Braun Medical, Inc. · Status: Terminated

Recall Action Class: N/A Date Initiated: 2005-09-15 Recall record compiled from public FDA source records.

Recall Parameters & Description

Normalized public record details for FDA recall code Z-0003-06.

Recall Res Number
Z-0003-06
Recalling Firm / Manufacturer
B. Braun Medical, Inc.
FEI Number
2523676
Recall Status
Terminated
Recall Classification
N/A
Date Initiated
2005-09-15
Date Posted
2005-10-04
Date Terminated
2006-03-23
Product Code
FRO
Event Number
33598
Product Quantity
60 units
Product Description D-Stat Dry Hemostatic Bandage. The product is an adhesive bandage.
Reason for Recall package sealing defect - product may not be sterile
Action Details 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 Pattern 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.
Code Information / Serial Numbers Lot numbers 301323A and 301393

Related Establishments / Registrations

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