Events

Recall of Device Recall Cook Medical

According to U.S. Food and Drug Administration, this recall involved a device in United States that was produced by Cook Inc..

What is this?

A correction or removal action taken by a manufacturer to address a problem with a medical device. Recalls occur when a medical device is defective, when it could be a risk to health, or when it is both defective and a risk to health.

Learn more about the data here
  • Type of Event
    Recall
  • Event ID
    73056
  • Event Risk Class
    Class 1
  • Event Number
    Z-0802-2016
  • Event Initiated Date
    2016-01-06
  • Event Date Posted
    2016-02-24
  • Event Status
    Terminated
  • Event Country
    United States
  • Event Terminated Date
    2017-08-23
  • Event Source
    USFDA
  • Event Source URL
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=142933
  • Notes / Alerts
    U.S. data is current through June 2018. All of the data comes from the U.S. Food and Drug Administration, except for the category Manufacturer Parent Company.
    The Parent Company was added by ICIJ.
    The parent company information is based on 2017 public records.
  • Extra notes in the data
    Catheter, percutaneous - Product Code DQY
  • Reason
    A manufacturing process may lead to catheter tip fracture and or separation. potential adverse events may include loss of device function, medical intervention to retrieve a separated segment, or complications resulting from a separated tip occluding blood flow to end organs. these catheters are used in venous or arterial pressure monitoring, blood sampling, and administration of drugs and fluids.
  • Action
    On 1/6/2016, URGENT: MEDICAL DEVICE RECALL notifications were sent to the affected distributors and hospital Risk Management/Recall Administration via courier with instructions for identifying and returning the affected product. The recall notification included a description of the reason for the recall, affected product, consignee responsibilities, and instructions for responding to the formal recall notification. Should you have any questions or concerns, please do not hesitate to contact Cook Medical Customer Relations at (800) 457-4500 or 1(812) 339-2235.

Device

Device Recall Cook Medical
  • Model / Serial
    RPN/Catalog number: C-PMS-250-RA C-PMS-251-RA C-PMS-300-RA C-PMS-300-RA-CHOP C-PMS-301J-RA C-PMS-301-RA C-PMS-400-RA C-PMSY-250-RA C-PMSY-300-RA C-PMSY-301-RA  Lots: 6049998 6160195 6160212 NS5898558 NS6063328 NS6178204 NS6178206 5895605 6191185 5793196 5800313 5800443 5800569 5806981 5810905 5810917 5824484 5824546 5824547 5824548 5866984 5866985 5866986 5870319 5881447 5881519 5889496 5891905 5911486 5922847 5922848 5925742 5928632 5939446 5939447 5939448 5976502 6025016 6025094 6033768 6034981 6034983 6050000 6062738 6062742 6067675 6067676 6075206 6075207 6083936 6083954 6083985 6083986 6129056 6148790 6160236 6165591 6174974 6175289 6191362 6269150 NS6063331 NS6108226 NS6170739 NS6170767 5905252 6003109 NS6072553 5793197 5800571 5800572 5824485 5824551 5845063 5864072 5866988 5873125 5881151 5881152 5884641 5884642 5889464 5892063 5892064 5922850 5939431 5942091 5951549 5953768 5954322 5967404 5974281 5994817 5996926 6003161 6003162 6017048 6025095 6025145 6034984 6042699 6050002 6075210 6075211 6075212 6081723 6083988 6100756 6124809 6125111 6148791 6153122 6160239 6160240 6168131 6171368 6187477 6250532 6059759 NS6047396 NS6047397 NS6047398 NS6047399 NS6047440 NS6047442 6124812 5793192 5824526 5884647 5892068 5942090 5967410 6003167 6059765 6134128 6153124 6168137 6254068 5793193 5866995 5892069 5942092 6003168 6025099 6067664 6168138
  • Product Classification
    Cardiovascular Devices
  • Device Class
    2
  • Implanted device?
    No
  • Distribution
    Worldwide Distribution - US Nationwide including DC and PR including the countries of Australia, Germany, China, Chile, Dominican Republic, Panama, Israel, Brazil, Canada
  • Product Description
    Radial Artery Pressure Monitoring Catheter Sets and Trays || The subject sets and trays are comprised of a single-lumen uncoated or heparin-coated catheter. Product catalog numbers with heparin coating are designated by the suffix BH.
  • Manufacturer
    Cook Inc.

Manufacturer

Cook Inc.
  • Manufacturer Address
    Cook Inc., 750 N Daniels Way, Bloomington IN 47404-9120
  • Manufacturer Parent Company (2017)
    Cook Group Incorporated
  • Source
    USFDA