D-Stat 2 Dry Hemostatic Bandage, model number 3010. Sterile, latex free single use device. Vascular Solutions, Inc. 6464
FDA device recall Z-0144-06 · posted 2005-11-16 · Terminated
Recall details
- Recalling firm
- Vascular Solutions, Inc.
- 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.
- Action taken
- 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.
- Root cause
- Other
- Status
- Terminated
- Product code
- FRO
- Quantity affected
- 20
- 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: Ital
- Date initiated
- 2005-09-09
- Date posted
- 2005-11-16
- Date terminated
- 2006-11-13
- Location
- Osseo, MN
Monitor recalls programmatically
Recalls and clearances share one API, with change alerts when new recalls post.
Related 510(k) clearances
| Record | Firm | Date |
|---|---|---|
| VASCULAR SOLUTIONS D-STAT 2 DRY HEMOSTATIC BANDAGE (K033709) | Vascular Solutions, Inc. | 2003-12-18 |