Events

Recall of Y-TYPE BLOOD ADMIN SET

According to Health Canada (via FOI), this recall involved a device in Canada that was produced by ICU MEDICAL 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
    113349
  • Event Risk Class
    III
  • Event Initiated Date
    2017-08-03
  • 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
    Some devices were labelled as "does not contain dehp" even though the product may potentially contain small amounts of dehp. the company has not received complaints or reports of any patient injury associated with this mislabelling.

Device

Y-TYPE BLOOD ADMIN SET
  • Model / Serial
    Model Catalog: B9220 (Lot serial: 3426308); Model Catalog: B9405 (Lot serial: 3347144); Model Catalog: B9220 (Lot serial: 3347144); Model Catalog: B9405 (Lot serial: 3332396); Model Catalog: B9220 (Lot serial: 3332396); Model Catalog: B9405 (Lot serial: 3343695); Model Catalog: B9220 (Lot serial: 3343695); Model Catalog: B9405 (Lot serial: 3426308); Model Catalog: K098-001 (Lot serial: 3364299); Model Catalog: K098-001 (Lot serial: 3396263); Model Catalog: K098-001 (Lot serial: 3332425); Model Catalog: MC33481 (Lot serial: 3389253); Model Catalog: MC33481 (Lot serial: 3371297); Model Catalog: MC33481 (Lot serial: 3332863); Model Catalog: MC33481 (Lot serial: 3356773); Model Catalog: MC33481 (Lot serial: 3344272); Model Catalog: MC33481 (Lot serial: 3367490)
  • Product Description
    Y-Type Blood Set w/170 Micron Filter Hand Pump Clave Rotating Luer;100" (254 cm) 20 Drop Y-Type Blood Set w/200 Micron Filter Hand Pump 2 Clave Rotating Luer w/Filter Cap;164"(417cm) 20 Drop Y-Type Blood Admin Set w/200 Micron Filter Hand Pump 4 Gang 4-Wa
  • Manufacturer
    ICU MEDICAL INC.

Manufacturer

ICU MEDICAL INC.
  • Manufacturer Address
    SAN CLEMENTE
  • Manufacturer Parent Company (2017)
    ICU Medical, Inc.
  • Source
    HC