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Terminated

D-Stat Dry Hemostatic Bandage. The product is an adhesive bandage.

FDA Recall Z-0003-06 · Posted 2005-10-04

Recalling FirmB. Braun Medical, Inc.
Recall StatusTerminated
Product CodeFRO
Date Initiated2005-09-15
Date Terminated2006-03-23
Product Quantity60 units

Reason for Recall

package sealing defect - product may not be sterile

Firm 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.

Root Cause

Other

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.

Related FDA 510(k) Records

Devices referenced by this recall via K-numbers.

K030836D-STAT-DRY HEMOSTATIC BANDAGE; D-STAT RADIAL HEMOSTATIC BANDAGEVascular Solutions, Inc. · 2003-09-17

Official Source

View FDA Recall →

Source: FDA Enforcement Report / Recall database. Always confirm against the official FDA record.

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