Recalls / —

—#42138

Product

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

FDA product code

FRO — Dressing, Wound, Drug

Device class

Class U

Medical specialty

Unknown

510(k) numbers

K030836

Affected lot / code info

Lot numbers 301323A and 301393

Why it was recalled

package sealing defect - product may not be sterile

Root cause (FDA determination)

Other

Action the firm took

The recalling firm issued a recall letter dated 9/15/05 informing their accounts of the problem and the need to return the product.

Recalling firm

Firm

B. Braun Medical, Inc.

Address

901 Marcon Blvd, Allentown, Pennsylvania 18109-9512

Distribution

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.

Timeline

Recall initiated

2005-09-15

Posted by FDA

2005-10-04

Terminated

2006-03-23

Status

—

Source: openFDA Device Recall endpoint. Recall record ID #42138. The FDA issues recall classifications as health-hazard assessments, not legal findings; for legal claims consult a licensed attorney.