Events

Recall of CARDIOVASCULAR PROCEDURE KIT (X-COATED PERFUSION PACK)

According to Health Canada (via FOI), this recall involved a device in Canada that was produced by RYAN MEDICAL DISTRIBUTORS 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
    38853
  • Event Risk Class
    III
  • Event Initiated Date
    2013-06-11
  • Event Country
    Canada
  • Event Source
    HC
  • Notes / Alerts
    Canadian data is current through March 2018. All of the data comes from Health Canada, except for the categories Manufacturer Parent Company and Product Classification.
    The Parent Company and the Product Classification were added by ICIJ.
    The parent company information is based on 2017 public records. The device classification information comes from FDA’s Product Classification by Review Panel, based on matches of recall data from the U.S. and Canada.
  • Extra notes in the data
  • Reason
    The over-pressure safety valves that are the subject of this recall (ln130b) are not cleared by the fda with an indication for use on the arterial side of the extracorporeal bypass circuit. these devices are cleared with an indication for use on the venous side of the extracorporeal circuit.

Device

CARDIOVASCULAR PROCEDURE KIT (X-COATED PERFUSION PACK)
  • Model / Serial
    Model Catalog: 74237-01 (Lot serial: > 10 numbers contact mfg); Model Catalog: 74006 (Lot serial: > 10 numbers contact mfg); Model Catalog: 73679-01 (Lot serial: > 10 numbers contact mfg); Model Catalog: 73673-02 (Lot serial: > 10 numbers contact mfg); Model Catalog: 74340 (Lot serial: > 10 numbers contact mfg); Model Catalog: 74226 (Lot serial: > 10 numbers contact mfg); Model Catalog: 72987 (Lot serial: QA28); Model Catalog: 72987 (Lot serial: QA07); Model Catalog: 72987 (Lot serial: PN19); Model Catalog: 72987 (Lot serial: NP12); Model Catalog: 72987 (Lot serial: PE30); Model Catalog: 72987 (Lot serial: PD05); Model Catalog: 72987 (Lot serial: PL17)
  • Product Description
    CARDIOVASCULAR PROCEDURE KIT (X-COATED PERFUSION PACK)
  • Manufacturer
    RYAN MEDICAL DISTRIBUTORS INC.

Manufacturer

RYAN MEDICAL DISTRIBUTORS INC.