Recall Z-0142-06 ยท FRO Dressing, Wound, Drug
Vascular Solutions, Inc.
D-Stat Dry Hemostatic Bandage, model number 3000. Sterile, latex free single use device. Vascular Solutions, Inc. 6464 Sycamore Court, Minneapolis, MN 55369 USA. Each D-Stat Dry hemostatic bandage (D-Stat Dry) consists of the following components: -Lyophilized pad consisting of thrombin, sodium carboxylmethyulcellulose and calcium chloride in a nonwoven gauze; -Adhesive bandage
| Date | Nov 16, 2005 (initiated Sep 9, 2005) |
| Status | Terminated |
| 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 | 9040 |
| 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 |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
| K030836 | D-STAT-DRY HEMOSTATIC BANDAGE; D-STAT RADIAL HEMOSTATIC BANDAGE Vascular Solutions, Inc., Sep 17, 2003 |