Vascular Solutions, Inc. D-Stat Hemostat Band, model number 3500. Sterile, latex free single use device. Vascular Solutions, Inc. 6464 Sycamore Court, Minneapolis, MN 55369 USA. Each D-Stat Radial hemostatic band (D-Stat Radial) consists of the following components: -Lyophilized pad consisting of thrombin, sodium carboxylmethyulcellulose and calcium chloride in a nonwoven gauze; -Application device consisting of an adjustable retention strap, collar and attached gauze pad. Recall

Check Your Product

According to the U.S. Food and Drug Administration (FDA)

Reason for Recall

As stated by FDA

A defect affecting the seals of the paper pouch holding the adhesive bandage provided with the D-Stat products was noted during manufacturing. The integrity of the seals of the D-stat Dry pads which are packaged separately in a foil pouch is not in question.

Recommended Action

Per FDA guidance

Urgent Medical Device Safety Information, dated 09/09/05, was sent to all affected customers via Fed Ex beginning 09/09/05. The letter informed the customers of the issue and askes customers to sequester affected product. A Vascular Solutions, Inc. Sales Representative will visit locations to remove and replace affected product beginning 09/19/05.

Distribution

As reported by FDA

AL, AZ, AR, CA, CO, CT, FL, GA, IL, IN, IA, KS, KY, LA, MD, MA, MI, MN, MS, MO, MT, NE, NV, NH, NJ, NM, NY, NC, OH, OK, PA, RI, SC, TX, UT, VA, WV, WI, DC, PR