Devices

Device Recall Pressure Monitoring Kit

  • Model / Serial
    0511829, 0519808, 0522673, 0537066, 0538520, 0544571, 0548624, 0552118, 0555878, 0557544, 0563808, 0565139, 0571582, 0575070, 0578021, 0578529, 0579318, 0580173, 0582267, 0584399, 0587165, 0589587, 0592742, 0593799, 0595311, 0595312, 0604098.
  • Product Classification
    Cardiovascular Devices
  • Device Class
    2
  • Implanted device?
    No
  • Distribution
    Worldwide Distribution -- USA (nationwide )including the states AR, CA, FL, GA, MO, MT, NC, ND, OK, OR, PA, TN, TX, UT, VA, WA and WY, and the countries of Argentina, Belgium, Chile, Colombia, Costa Rica, Dominican Republic, Ecuador, Guatamala, Honduras, Hong Kong, Indonesia, Kuwait, Malaysia, Mexico, Pakistan, Panama, Philippines, Singapore, South Korea, Thailand, United Arab Emirates, Uruguay and Vietnam
  • Product Description
    Pressure Monitoring Kit, Catalog 16066100, Terumo Cardiovascular Systems Ann Arbor MI. The pressure monitoring kit is indicated for sterile single use with the reusable pressure transducer.
  • Manufacturer
    Terumo Cardiovascular Systems Corporation
  • 1 Event

Manufacturer

Terumo Cardiovascular Systems Corporation
  • Manufacturer Address
    Terumo Cardiovascular Systems Corporation, 6200 Jackson Road, Ann Arbor MI 48103-9586
  • Manufacturer Parent Company (2017)
    Terumo Corp.
  • Source
    USFDA

18 devices with a similar name

Learn more about the data here

Device Recall Pressure Monitoring Kit
  • Model / Serial
    Model # Lot # Expiration Date PX2X3 59987950 3/12/2017 PX2X3 60008882 3/24/2017 PX2X3 60043561 5/1/2017 PX3X3272 59994227 3/8/2017 PX3X3272 60025936 4/15/2017 PX3X3AN 60030889 4/17/2017 PX3X3AN 60008883 3/26/2017 PXAK2066 60025499 2/27/2017 PXAVMP3 60036757 4/27/2017 PXMK1970 60001398 4/16/2017 PXMK2043 59994210 3/9/2017 PXMK2043 60001412 3/17/2017 PXMK2043 60020166 4/5/2017 PXMK2043 60030868 4/26/2017 PXMK2144 60019038 4/17/2017 PXMK2217 59994267 3/12/2017 PXMK2217 60030969 4/20/2017 PXMK2217 60020235 4/15/2017 PXVK0458 59983333 4/6/2017 PXVK1079 59994195 3/11/2017 PXVK1079 60020153 3/31/2017 PXVMP2X31 59998630 3/12/2017 PXVMP2X31 59999004 3/13/2017 PXVMP2X31 59999006 3/13/2017 PXVMP3X31 59994223 3/13/2017 PXVMP3X31 60049581 4/23/2017 PXVMP3X32 60025874 3/31/2017 T001746A 60036771 4/30/2017 T001759A 59976102 3/10/2017 T001759A 60014134 3/31/2017 T001759A 60020177 4/13/2017 T001759A 60049570 5/4/2017 T330V11A 60014160 3/29/2017 T333F00A 59987991 3/9/2017 T333F00A 60001468 3/16/2017 T333F00A 60022033 3/13/2017 T334041A 60008925 3/25/2017 T334041A 60049612 5/5/2017 T336547B 60008919 3/27/2017 T337305B 59987992 3/11/2017 T337305B 60001473 3/17/2017 T391314A 60020222 3/29/2017 T391T01A 60014163 3/30/2017 T395606B 60022034 3/13/2017 T395606B 60025971 4/14/2017 T430140A 60014177 3/31/2017 T430609A 60001486 3/16/2017 T430609A 60043616 4/27/2017 T431305A 60008942 3/25/2017 T431305A 60059909 5/8/2017 T440B20B 59994257 3/13/2017 T440B20B 60030953 4/17/2017 T440B21A 60025987 4/15/2017 T440B21A 59976182 3/11/2017 T440B26B 60030938 4/17/2017 T440B26B 60049616 5/4/2017 T443422A 60036750 4/29/2017 T443422A 60020223 4/15/2017 T449103B 60008929 3/24/2017 T449103B 60043599 4/28/2017 T450544A 60030944 4/20/2017 T494C00B 60020168 3/19/2017 T494C00B 60001415 3/25/2017 T494C00B 60043543 4/21/2017 T530116B 60022035 3/13/2017 T530116B 60008937 3/24/2017
  • Product Classification
    Cardiovascular Devices
  • Device Class
    2
  • Implanted device?
    No
  • Distribution
    Worldwide Distribution - US nationwide, Australia, Austria, Canada, China, Colombia, Croatia, Denmark, France, Germany, Great Britain, Italy, Netherlands, New Zealand, Sweden, and Slovenia.
  • Product Description
    Edwards Pressure Monitoring Kit with TruWave disposable pressure transducer. A sterile, single-use kit that monitors pressures when attached to pressure monitoring catheters. For use on patients requiring intravascular, intracranial, or intrauterine pressure monitoring.
  • Manufacturer
    Edward Lifesciences, Llc
Device Recall Pressure monitoring kit
  • Model / Serial
    Part number 687196, Lot number 410174.
  • Product Classification
    Cardiovascular Devices
  • Device Class
    2
  • Implanted device?
    No
  • Distribution
    Nationwide, including VA facilities in NY, SD, IL, OH and military facilities in GA, NC and Guam. Foreign distribution to Japan.
  • Product Description
    BD DTX Plus, Custom single-line pressure monitoting kit.
  • Manufacturer
    Becton Dickinson Medical Systems
Device Recall Pressure monitoring kit
  • Model / Serial
    Part number 687206, Lot numbers: 411062, 411539, 501148.
  • Product Classification
    Cardiovascular Devices
  • Device Class
    2
  • Implanted device?
    No
  • Distribution
    Nationwide, including VA facilities in NY, SD, IL, OH and military facilities in GA, NC and Guam. Foreign distribution to Japan.
  • Product Description
    BD DTX Plus, Custom triple-line pressure monitoring kit.
  • Manufacturer
    Becton Dickinson Medical Systems
Device Recall Pressure monitoring kit
  • Model / Serial
    Part Number 682000, Lot Numbers: 407104, 407387
  • Product Classification
    Cardiovascular Devices
  • Device Class
    2
  • Implanted device?
    No
  • Distribution
    Nationwide, including VA facilities in NY, SD, IL, OH and military facilities in GA, NC and Guam. Foreign distribution to Japan.
  • Product Description
    BD DTX Plus, 60'' complete single-line pressure monitoring kit.
  • Manufacturer
    Becton Dickinson Medical Systems
Device Recall Pressure monitoring kit
  • Model / Serial
    Part Number 682007, Lot Number 407467
  • Product Classification
    Cardiovascular Devices
  • Device Class
    2
  • Implanted device?
    No
  • Distribution
    Nationwide, including VA facilities in NY, SD, IL, OH and military facilities in GA, NC and Guam. Foreign distribution to Japan.
  • Product Description
    BD DTX Plus, 60'' complete dual-line pressure monitoring kit.
  • Manufacturer
    Becton Dickinson Medical Systems
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