Vascular Solutions — Class I medical device recall Z-0955-2013
Terminated recall by Vascular Solutions, Inc., reported 2013-03-27, distributed in AL, AR, AZ, CA, CO, CT, DC, DE…. Risk that air may be introduced into the device which may lead to an air embolism.
| Recall number | Z-0955-2013 |
|---|---|
| Product type | Medical device |
| Classification | Class I |
| Status | Terminated |
| Voluntary or mandated | Voluntary |
| Recalling firm | Vascular Solutions, Inc., Maple Grove, MN, United States |
| Recall initiated | 2013-02-27 |
| Classified | 2013-03-20 |
| Reported by FDA | 2013-03-27 |
| Terminated | 2013-08-05 |
| Distributed | AL, AR, AZ, CA, CO, CT, DC, DE, FL, GA, HI, IA, IL, IN, KS, KY, LA, MA, MD, MI, MN, MO, MS, NC, ND, NE, NJ, NV, NY, OH, OK, OR, PA, SC, SD, TN, TX, UT, VA, VT, WA, WI, WV |
| Countries outside the US | AT, BE, CH, DE, DK, EG, ES, GB, GR, HK, HU, IE, IN, IT, KR, MX, NL, NO, PL, PT, SE, SI, TR |
| Quantity | 79,869 |
| Lot numbers | 27215, 27216, 27217, 27294, 27295, 27334, 27390, 27391, 27392, 27393, 27394, 27395, 27396, 27397, 27398, 27399, 27400, 27401, 27402, 27403, 27646, 27647, 27648, 27649, 27650, 27651, 27652, 27653, 27654, 27655, 27656, 27657, 27658, 27659, 27660, 27779, 28001, 28002, 28003, 28004 and 107 more |
| Model numbers | 8210, 8211, 8215, 8216, 8241, 8242, 8244, 8272, 8274, FH101, FH101-25, FH101-50, FH101-T, FH102, FH102-25, FH102-50, FH102-T |
Product
Vascular Solutions, Inc., Guardian II and Guardian II NC Hemostasis Valve, used in cardiopulmonary bypass. Model numbers: FH101, FH101-T, FH101-25, FH101-50, 8210, 8211, FH102, FH102-T, FH102-25, FH102-50, 8215, 8216, 8241, 8242, 8244, 8272 and 8274. Vascular Solutions Zerusa Limited. Intended to maintain hemostasis during the use of diagnostic/interventional devices during diagnostic/interventional procedures.
Reason for recall
Risk that air may be introduced into the device which may lead to an air embolism.
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-0955-2013. 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.