Z-0143-06

D-Stat Hemostat Band, model number 3500. Sterile, latex free single use device. Vascular Solutions, Inc. 6464...

Name: Z-0143-06 D-Stat Hemostat Band, model number 3500. Sterile, latex free single use device. Vascular Solutions, Inc. 6464...
Creator: Vascular Solutions, Inc.
Published: 2005-09-09
License: https://open.fda.gov/license/

Vascular Solutions LLC / initiated 2005-09-09 / Terminated / root cause: packaging

FDA source

Vascular Solutions, Inc. began a recall of D-Stat Hemostat Band, model number 3500. Sterile, latex free single use device. Vascular Solutions, Inc. 6464 Sycamore Court, Minneapolis, MN 55369 USA. Each... on 2005-09-09. The reason FDA records is "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...". As of 2026-09-10, the recall status on record is Terminated, and MDM tags the root cause as packaging.

Recall record

Recall number: Z-0143-06
Status: Terminated
Initiated: 2005-09-09
Posted: 2005-11-16
Terminated: 2006-11-13
Recalling firm: Vascular Solutions LLC
Product: 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.
Product code: FRO Dressing, Wound, Drug
Reason for recall: 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.
Root cause tag: packaging
FDA root cause: Other
Action: 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.
Quantity in commerce: 415
Distribution: Within the US to AL, AR, AZ, CA, CO, CT, DC, FL, GA, IA, IL, IN, KS, KY, LA, MA, MD, MI, MN, MO, MS, MT, NC, NE, NH, NJ, NM, NV, NY, OH, OK, PA, PR, RI, SC, TX, UT, VA, WI and WV. OUS to include: Italy, United Kingdom
Product codes and lots: 301384, 301385 and 301386

Product code FRO

K030836UnclassifiedD-Stat-Dry Hemostatic Bandage; D-Stat Radial Hemostatic BandageVascular Solutions, Inc. / cleared 2003-09-17

MDM coverage of this record lists here, newest first.

About this record

Sourced from the FDA device recall database and the FDA enforcement reports, both ingested from openFDA. The recall record supplies the product, the reason and the product code; the enforcement report supplies the classification. The two datasets are exported by FDA on different days, and the date above is the older of the two, so nothing on this page is newer than it says.

MDM adds the root cause tag, derived from FDA’s own root cause text, and the cross-links to the product code, the clearances named on the record and MDM coverage. Where a recall has not been joined to an enforcement report, no classification is shown.

Data as of 2026-09-30, the FDA export date for this dataset. Page last changed 2026-09-05. View this recall on fda.gov (opens on fda.gov)