Z-2030-2014 Class II Terminated
FDA device recall Z-2030-2014 was initiated by Terumo Cardiovascular Systems Corporation on Apr 14, 2014 and is designated Class II. Reason for recall: During set-up and priming of the bypass circuit, leaks were detected on the centrifugal pumphead. The recall status is terminated (terminated Sep 7, 2016). Affected quantity: 256 kits.
Recall Details
- Product Type
- Devices
- Report Date
- Jul 23, 2014
- Initiation Date
- Apr 14, 2014
- Termination Date
- Sep 7, 2016
- Voluntary/Mandated
- Voluntary: Firm initiated
- Product Quantity
- 256 kits
Product Description
Cardiovascular Procedure Kit containing Disposable Centrifugal Pumphead with or without X-Coating, sterile single use. Catalog numbers 73431, 73813-03, 74277, 72481-01, 72427, 70947-03, 74570-01, 74031-01, 73312-01, 74362, 74928, 74928-01, 72997-03, 74277, 70334-03, 73230, 73728, 71537, 73605-01, 74482-01, 74857-01, 74916, 73928-02, 70123-02, 71853-02, 72997-03, 74766, 71537, 73728, 72269, 74466, 71317-02 72991-02, 74951, 74336, 74121-01, 72941-01, 73315-03, 74559, 74277, 71382-01, 73108-02, 74178-03, 71598-02, 73108-02, 74618-01, 70334-03, 74802-01, 74916, 71932-02, 70951-03, 73957-01, 74857-01, 70957-02, 73449-01, 73124, 71546-02, 72892-01, 74431, 72370, 73913-01, 73957-01, 75028, 71820-01, 74201, 74402, 73891-01, 73865, 73972, 71175-01, 73208-03, 72669-02, 70533-09, 72275-01, 74369, 74321-01, 73175, B73235, 74459, 73931, 74262-01, 71002-01, 74879-01, 71801-01, 72384, 74365, 74366, 74348-01, 72072-02, 74048, 70932-03, 73407, 74879-01, 73820-01, 74161-01, 72991-02, 73288-01, 70016, 70466-08, 70188-04, 72238-02, 72817-01, 71103-02, 71717-01, 70957-02, 70196-02, 73872-02, 71896-02, 73191-01, 70977-05, 73438, 73201-01, 74671, 70367-07, 73276-02, 74482-01, 73551-02, 71537, 74348-01, 73211-01, 74430, 72026-03, 74502, 74873, 73652-01, 74163-02, 71733-02, 70075-06, 72846, 73820-01, 75063, 74155-01, 74454-01, 73428-01, 73442-01, 70664-01, 70012-05, 70099-03, 70159-05, 70917, 72965-02, 73645-01, 74417, 73346, 74433, 74737, 73055-02, 70227-04, 70880-05, 71934-02, 72073-01, 72149-01, 74120-01, 72370, 73662-03, 74251, 73872-02, 70658-09, 74550, 74124, 74096-01, 74203, 70174-09, 71485-01, 71905-01, 73124, 73874, 74467-01, 8327TXC-08, 8365TXC-01, 8390TXC, 74433, and 74737. For use only in the extracorporeal circuit for the cardiopulmonary bypass procedures.
Reason for Recall
During set-up and priming of the bypass circuit, leaks were detected on the centrifugal pumphead.
Distribution Pattern
Nationwide Distribution
Code Information
Pack Lot Nos. RA27T, RA20, RA06T, QP09A, QN18A, RA06A, QP16A, RA20A, RC03A, and RC17T. QM21, RA27, RA27R, QN07, QM28, QF13A, QM21, QN25, QP16, QM14, QN18, QN11, QN04, RA13, QF06R, RC10, QM14T, QM21A, RC24, QF06, QP09, QF20A, QF13R, QF06RT, QG03RA, QG17, QL03, QM14T, QN25A, QE29, QE29T, QL16, QM28A, QM28C, QM28T, QK05, QK05AC, QK26, QK26A, QL02, QL16, QL16A, QL23, QN11A, QF20, QH08, QP02A, QP16, RC03, RA02, RA06, RC24, QK26, QE15, QM21T, QP02A, RA27A, QM07, QL02, QH08, QN25, QG17, QF06, QF06T, QF13, QF13T, QF13TA, QN18, QA21R, QE29T, QF28, RC03, QF28, RC17, QF06, RA13, QF20, QL03, RA27A, QH22, QG10, and RC24.
Source
- Dataset
- openFDA device recall enforcement reports
- FDA record
- This recall in openFDA (JSON)
- Enforcement Report
- Search FDA's Enforcement Report for Z-2030-2014
- openFDA file date
- Oct 23, 2026
- Loaded by RegDataLab
- Oct 25, 2026