Events

Recall of SARNS DUAL-STAGE MALLEABLE VENOUS RETURN CATHETER

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
    67996
  • Event Risk Class
    II
  • Event Initiated Date
    2014-07-23
  • 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
    During an inspection of finished product terumo cardiovascular systems (terumo cvs) identified the presence of loose fiber particulate that exceeded specification for the finished sarns and terumo cannulae. terumo cvs has not received any reports of loose particulate during clinical use. tcvs has decided to remove all affected lots that were distributed.

Device

SARNS DUAL-STAGE MALLEABLE VENOUS RETURN CATHETER
  • Model / Serial
    Model Catalog: 4936 (Lot serial: >100 numbers contact mfg.); Model Catalog: 4881 (Lot serial: >10 numbers contact mfg.); Model Catalog: 9453 (Lot serial: >10 numbers contact mfg.); Model Catalog: 4951 (Lot serial: >100 numbers contact mfg.); Model Catalog: 4949 (Lot serial: >100 numbers contact mfg.); Model Catalog: 5767 (Lot serial: >100 numbers contact mfg.); Model Catalog: 5762 (Lot serial: >100 numbers contact mfg.); Model Catalog: 5761 (Lot serial: >100 numbers contact mfg.); Model Catalog: 813547 (Lot serial: >100 numbers contact mfg.); Model Catalog: 813546 (Lot serial: >100 numbers contact mfg.); Model Catalog: 813544 (Lot serial: >100 numbers contact mfg.); Model Catalog: 4950 (Lot serial: >1000 numbers contact mfg.); Model Catalog: 4948 (Lot serial: >1000 numbers contact mfg.); Model Catalog: 15949 (Lot serial: >10 numbers contact mfg.); Model Catalog: 813588 (Lot serial: >100 numbers contact mfg.); Model Catalog: 813586 (Lot serial: >100 numbers contact mfg.); Model Catalog: 813583 (Lot serial: >1
  • Product Description
    Sarns Dual-Stage Malleable Venous Return Catheter
  • Manufacturer
    RYAN MEDICAL DISTRIBUTORS INC.

Manufacturer

RYAN MEDICAL DISTRIBUTORS INC.