Recall Z-0955-2013— Vascular Solutions, Inc.
Class I · Terminated
Class I FDA medical device recall by Vascular Solutions, Inc., initiated 2013-02-27, terminated 2013-08-05. It names 3 FDA 510(k) clearances: K122301, K101113, K092711. 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: Risk that air may be introduced into the device which may lead to an air embolism..
- Recalling firm
- Vascular Solutions, Inc.
- Classification
- Class I
- Status
- Terminated
- Initiated
- 2013-02-27
- Terminated
- 2013-08-05
- Firm location
- Maple Grove, MN, United States
510(k) clearances named in this recall
3 on FDA's record- K122301 — GUARDIAN II HEMOSTASIS VALVE GUARDIAN II NC HEMOSTASIS VALVE
- K101113 — GUARDIAN II NC HEMOSTASIS VALVE
- K092711 — GUARDIAN II HEMOSTASIS VALVE
K-numbers as listed on FDA's Recall Enterprise System record for this event (openFDA device/recall k_numbers). The recall may also cover devices cleared under other submissions not named here.
Product description
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.
Data sourced from openFDA. This site is unofficial and independent of the FDA.