FDA Medical Device Recalls (openFDA)
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 number
- Z-0143-06
- Recalling firm
- Vascular Solutions, Inc.
- 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.
- Status
- Terminated
- Initiated
- 2005-09-09
- Posted
- 2005-11-16
- Terminated
- 2006-11-13
- Reason
- 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
- 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
- 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
- Lot, serial or model codes
- 301384, 301385 and 301386
- 510(k) numbers
- ["K030836"]
- PMA numbers
- not on file
- Product code
- FRO
- Firm FEI
- 3002827704
- Firm city
- Osseo
- Firm state
- MN
- Firm country
- not on file
Where this comes from
- Register
- FDA Medical Device Recalls (openFDA)
- Publisher
- U.S. Food and Drug Administration (openFDA)
- File
- device-recall-0001-of-0001.json.zip
- sha256
- b87518bfe2e8
- Size
- 288210821 bytes
- Published
- 2026-09-28
- Read
- 2026-09-29T08:25:23.626Z
- Source file
- Source file retained · verify
- Refresh due
- 2026-10-06
Unless otherwise noted, the content, data, documentation, code, and related materials on openFDA is public domain and made available with a Creative Commons CC0 1.0 Universal dedication.
Cite as
FDA Medical Device Recalls (openFDA) (U.S. Food and Drug Administration (openFDA)), device-recall-0001-of-0001.json.zip, sha256 b87518bfe2e8, published 2026-09-28