Guardian II Hemostasis Valve — Class II medical device recall Z-2400-2012
Terminated recall by Vascular Solutions, Inc., reported 2012-09-26, distributed nationwide. Vascular Solutions, Inc., became aware of a potential problem involving pouches missing a seal from Guardian I
| Recall number | Z-2400-2012 |
|---|---|
| Product type | Medical device |
| Classification | Class II |
| Status | Terminated |
| Voluntary or mandated | Voluntary |
| Recalling firm | Vascular Solutions, Inc., Maple Grove, MN, United States |
| Recall initiated | 2012-08-30 |
| Classified | 2012-09-17 |
| Reported by FDA | 2012-09-26 |
| Terminated | 2012-12-04 |
| Distributed | Nationwide (US) |
| Countries outside the US | IT, KR |
| Quantity | 3,500 units |
| Reason classes | packaging |
| Lot numbers | 22446, 27293, 27686 |
| Model numbers | 8210, FH102 |
Product
Guardian II Hemostasis Valve, Model 8210 and Guardian II NC Hemostasis Valve, Model FH102. Intended to maintain hemostasis during the use of diagnostic/interventional devices. The device is indicated for maintaining a seal around diagnostic/interventional devices with outside diameters up to 8.0F (2.67 mm or 0.105") during diagnostic/interventional procedures.
Reason for recall
Vascular Solutions, Inc., became aware of a potential problem involving pouches missing a seal from Guardian II (Model 8210) and Guardian II NC (Model FH102) Hemostasis Valve which poses a risk of product contamination.
Machine access
This record, with every extracted code, the verbatim FDA record and provenance, is available from the recall API: GET https://api.data.aroqon.com/v1/recalls/Z-2400-2012. Look up any UPC, UDI, NDC or lot with /v1/recalls/lookup?code=…. API docs · free and paid keys.
Source: U.S. Food and Drug Administration enforcement report via openFDA (CC0). Structured by Data Foundry (recall-structuring@2); last changed 2026-09-26. Not affiliated with or endorsed by FDA. Not medical or legal advice.