Vascular Solutions, Inc., Guardian II and Guardian II NC Hemostasis Valve, used in cardiopulmonary bypass. Model numbers
FDA device recall Z-0955-2013 · posted 2013-03-20 · Terminated
Recall details
- Recalling firm
- Vascular Solutions, Inc.
- Reason for recall
- Risk that air may be introduced into the device which may lead to an air embolism.
- Action taken
- Consignees were sent a Vascular Solutions "Urgent Medical Device Recall" letter dated February 28, 2013. The letter described the problem and the product involved in the recall. In addition, consignees were advised to identify the location of and immediately remove the recalled product from their inventory and secure it. Consignees were requested to complete and return the VSI Account Inventory Form. The letter also stated that VSI Customer Service would contact customers within 1-2 business days after receiving the completed VSI Account Inventory Form. All returned affected product will be replaced upon receipt. Customers are to contact their local Sales Representative if they have any questions or concerns regarding this recall.
- Root cause
- Vendor change control
- Status
- Terminated
- Product code
- DTL
- Quantity affected
- 79,869
- Distribution
- Worldwide Distribution -- USA, including the states of AL, AZ, AR, CA, CO, CT, DE, DC, FL, GA, HI, IL IN, IA, KS, KY, LA, MD, MA, MI, MN, MS, MO, NE, NV, NJ, NY, NC, ND, OH, OK, OR, PA, SC, SD, TN, TX
- Date initiated
- 2013-02-27
- Date posted
- 2013-03-20
- Date terminated
- 2013-08-05
- 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 |
|---|---|---|
| GUARDIAN II HEMOSTASIS VALVE GUARDIAN II NC HEMOSTASIS VALVE (K122301) | Vascular Solutions Zerusa , Ltd. | 2012-09-07 |
| GUARDIAN II NC HEMOSTASIS VALVE (K101113) | Zerusa Limited | 2010-05-21 |
| GUARDIAN II HEMOSTASIS VALVE (K092711) | Zerusa Limited | 2009-10-01 |