Vascular Solutions, SuperCross Microcatheter, Sterilized using ethylene oxide, Rx Only, Model numbers 5300 - 5307, 5324,
FDA device recall Z-0868-2013 · posted 2013-02-20 · Terminated
Recall details
- Recalling firm
- Vascular Solutions, Inc.
- Reason for recall
- Vascular Solutions, Inc has discovered a potential problem with a number of lots of Supercross microcatheters. A potential for surface contamination on aged catheters was observed during in-house testing.
- Action taken
- Vascular Solutions sent an "Urgent Medical device Recall" letter dated January 28, 29013 to all affected customers. The letter identified the affected product, described the problem and actions to be taken. The letter advised customers to remove the product from their inventory and to complete and return the VSI Account Inventory Form. For questions contact your local Sales Representative.
- Root cause
- Material/Component Contamination
- Status
- Terminated
- Product code
- DQY
- Quantity affected
- 4731
- Distribution
- Worldwide Distribution - USA Nationwide including the states of AL, AZ, AR, CA, CO, CT, DE, CD, FL, GA, HI, ID, IL ,IN, IA, KY, LA, ME, MD, MA, MI,MN, MO, MT, NE, NV, NH, NJ, NM, NY, NC, ND, OH, OK, O
- Date initiated
- 2013-01-29
- Date posted
- 2013-02-20
- Date terminated
- 2013-06-25
- Location
- Maple Grove, MN
Monitor recalls programmatically
Recalls and clearances share one API, with change alerts when new recalls post.
Related 510(k) clearances
| Record | Firm | Date |
|---|---|---|
| SUPERCROSS MICROCATHETER (130 CM), SUPERCROSS MICROCATHETER (150 CM) MODEL 5300, 5301 (K101659) | Vascular Solutions, Inc. | 2010-12-16 |