Events

Recall of TRANSPAC DISPOSABLE TRANSDUCER MONITORING KIT WITH INTRAFLO FLUSH

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
    149406
  • Event Risk Class
    II
  • Event Initiated Date
    2016-09-30
  • 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
    Icu medical inc. has identified a potential leak with certain monitoring kits that contain the transpac iv transducers. a small number of these devices may have the potential to leak or potentially introduce a small amounts of air into the line.

Device

TRANSPAC DISPOSABLE TRANSDUCER MONITORING KIT WITH INTRAFLO FLUSH
  • Model / Serial
    Model Catalog: 42587-05 (Lot serial: 3247898); Model Catalog: 42590-05 (Lot serial: 3247898); Model Catalog: 42587-05 (Lot serial: 3261651); Model Catalog: 42590-05 (Lot serial: 3261651); Model Catalog: 42590-05 (Lot serial: 3292882); Model Catalog: 42587-05 (Lot serial: 3292882); Model Catalog: 011-46104-41 (Lot serial: >10 numbers contact mfg.); Model Catalog: 42583-05 (Lot serial: >10 numbers contact mfg.); Model Catalog: 42584-05 (Lot serial: >10 numbers contact mfg.); Model Catalog: 42585-05 (Lot serial: >10 numbers contact mfg.); Model Catalog: 011-46101-92 (Lot serial: >10 numbers contact mfg.); Model Catalog: 42582-06 (Lot serial: 3264160); Model Catalog: 46107-53 (Lot serial: 3257008); Model Catalog: 42582-06 (Lot serial: 3257008); Model Catalog: 46107-53 (Lot serial: 3264160); Model Catalog: 46107-53 (Lot serial: 3264105); Model Catalog: 42594-05 (Lot serial: 3265442); Model Catalog: 42582-06 (Lot serial: 3264105); Model Catalog: 42641-06 (Lot serial: 3249806)
  • Product Description
    TRANSPAC DISPOSABLE TRANSDUCER MONITORING KIT WITH INTRAFLO FLUSH;TRANSPAC DISPOSABLE TRANSDUCER MONITORING KIT WITH 3 ML SQUEEZE FLUSH DEVICE;TRANSPAC IV DISPOSABLE TRANSDUCER WITH STOPCOCKS;TRANSPAC IV MONITORING KIT W/4 WAY STOPCOCK 3 WAY STOPCOCK AND
  • Manufacturer
    ICU MEDICAL INC.

Manufacturer

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