BEUDAMED
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    Heat Exchanger Coil (code Number 0006-0011) used in the ''Custom Cardiovascular Procedure Kits'' .

    FDA Recall
    Terminated ·Terumo Cardiovascular Systems Corp·Product code DTR·November 7, 2002

    Terumo Cardiovascular Procedure Kit Custom ADULT PACK P/N: 131351-02

    FDA Recall
    Terminated ·Terumo Cardiovascular Systems Corp·Product code DTR·June 8, 2010

    Terumo Cardiovascular Procedure Kit Custom X-COATED PERFUSION PACK P/N 71934

    FDA Recall
    Terminated ·Terumo Cardiovascular Systems Corp·Product code DTR·June 8, 2010

    Terumo Cardiovascular Procedure Kit Custom 1:1 CONDUCER/MP4 CRYSTALLOID CARDIOPLEGIA P/N 65246

    FDA Recall
    Terminated ·Terumo Cardiovascular Systems Corp·Product code DTR·June 8, 2010

    Terumo Cardiovascular Procedure Kit Custom CONDUCER/MP4 8:1 NO RECIRC. DOUBLE SPIKE P/N: 71032

    FDA Recall
    Terminated ·Terumo Cardiovascular Systems Corp·Product code DTR·June 8, 2010

    MAQUET PLEGIOX Cardioplegia Heat Exchanger The PLEGIOX Cardioplegia Heat Exchanger is used as part of a cardioplegia system to set and maintain temperature for given flow rates and within the given temperature range of blood cardioplegic and crystalloid cardioplegic solutions during extracorporeal circulation. The product is designed for single use only, for an application period of no longer than 6 hours.

    FDA Recall
    Terminated ·Maquet Cardiovascular Us Sales, Llc·Product code DTR·January 31, 2014

    Cardiovascular Procedure Kit X-Coated H/L pack with Cardioplegia, Item # 70067-03

    FDA Recall
    Terminated ·Terumo Cardiovascular Corporation·Product code DTR·June 8, 2010

    Terumo Custom Cardioplegia Delivery Sets Catalog Code: 204880 Product Usage: This is a replacement line to multiple Cardioplegia Delivery Sets-and includes the female luer connector" that is the subject of this correction/removal activity

    FDA Recall
    Terminated ·Terumo Cardiovascular Systems Corp·Product code DTR·March 1, 2011

    Terumo Cardiovascular Procedure Kit Custom X-COATED PUMP AND TABLE PACK W/8:1 CARDIOPLEGIA P/N 72642

    FDA Recall
    Terminated ·Terumo Cardiovascular Systems Corp·Product code DTR·June 8, 2010

    Terumo Cardiovascular Procedure Kit Custom ADULT PACK P/N 71546-01

    FDA Recall
    Terminated ·Terumo Cardiovascular Systems Corp·Product code DTR·June 8, 2010

    Terumo Cardiovascular Procedure Kit Custom X-COATED ADULT PRESTIGE PACK P/N 71544-01

    FDA Recall
    Terminated ·Terumo Cardiovascular Systems Corp·Product code DTR·June 8, 2010

    Terumo Cardioplegia Delivery Set- Item Number: 16130 Product Usage: The Cardioplegia Delivery Sets are indicated for delivery of cardioplegic solutions to the heart during cardiopulmonary bypass surgery.

    FDA Recall
    Terminated ·Terumo Cardiovascular Systems Corp·Product code DTR·March 1, 2011

    Sarns MP4 Cardioplegia Sets; catalog number 15501.

    FDA Recall
    Terminated ·Terumo Cardiovascular Systems Corp·Product code DTR·February 25, 2003

    Terumo Cardiovascular Procedure Kit Custom Open Perfusion Pack P/N 64937

    FDA Recall
    Terminated ·Terumo Cardiovascular Systems Corp·Product code DTR·June 8, 2010

    Terumo Cardiovascular Procedure Kit Custom 8:1 CARDIOPLEGIA SET P/N 70608-01

    FDA Recall
    Terminated ·Terumo Cardiovascular Systems Corp·Product code DTR·June 8, 2010

    Terumo Cardiovascular Procedure Kit Custom X-COATED ADULT PACK P/N 72846

    FDA Recall
    Terminated ·Terumo Cardiovascular Systems Corp·Product code DTR·June 8, 2010

    Model 5001102 MPS Delivery Set w/ arrest agent and additive cassettes, heat exchanger &10 ft. delivery tubing; Model 5001102-AS MPS Delivery Set with 6 ft. delivery tubing; Model 7001102 MPS Low Volume Delivery Set for use with cardiopulmonary bypass equipment.

    FDA Recall
    Terminated ·Quest Medical, Inc.·Product code DTR·October 28, 2015

    Cardiovascular Procedure Kit Custom 4:1 Myocardial Set, (MP4 w/ Coil Component Utilized), Item # 63485

    FDA Recall
    Terminated ·Terumo Cardiovascular Corporation·Product code DTR·June 8, 2010

    Cardiovascular Procedure Kit, (MP4 w/ Conducer Component Utilized), labeled in part ***RWJ Hospital***, Item # 71305-03

    FDA Recall
    Terminated ·Terumo Cardiovascular Corporation·Product code DTR·June 8, 2010

    Terumo Cardiovascular Procedure Kit Custom X-COATED HEART - LUNG PACK P/N: 70608-01

    FDA Recall
    Terminated ·Terumo Cardiovascular Systems Corp·Product code DTR·June 8, 2010