Guardian II Hemostasis Valve, models 8210 and 8211. The following models are only available Outside the US: FH101, FH101
FDA device recall Z-1275-2016 · posted 2016-04-07 · Terminated
Recall details
- Recalling firm
- Vascular Solutions, Inc.
- Reason for recall
- Vascular Solutions became aware of a potential problem with the click version of the Guardian II hemostasis valves. The low pressure seal may not close properly, which may allow air to be introduced into the device and may lead to risk of an air embolism.
- Action taken
- Consignees were sent on 3/4/2016 via first class mail a Vascular Solutions "Urgent Medical Device Recall" letter dated March 3, 2016. The letter described the problem and the product involved in the recall. It included the "Immediate Action Required of Customer / User" which instructed the customer to identify the product, remove it from inventory, place it in a secure area, and complete and return the VSI Account Inventory Form to the Customer Service Department.
- Root cause
- Employee error
- Status
- Terminated
- Product code
- DTL
- Quantity affected
- 5283
- Distribution
- Nationwide Distribution in the states of AL, AR, CA, CO, DE, FL, GA, ID, IL IN, IA,KY, LA, MD, MA, MI, MO, NE,NV, NH, NY, NC, OH, PA, SD, TN, TX, UT, VA, WA, and WV. OUS: Ireland
- Date initiated
- 2016-03-04
- Date posted
- 2016-04-07
- Date terminated
- 2016-10-19
- Location
- Maple Grove, MN
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Related 510(k) clearances
| Record | Firm | Date |
|---|---|---|
| GUARDIAN II HEMOSTASIS VALVE GUARDIAN II NC HEMOSTASIS VALVE (K122301) | Vascular Solutions Zerusa , Ltd. | 2012-09-07 |