Events

Recall of PRESSURE INJECTABLE PICC KIT

According to Health Canada (via FOI), this recall involved a device in Canada that was produced by TELEFLEX MEDICAL CANADA 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
    84138
  • Event Risk Class
    III
  • Event Initiated Date
    2017-04-07
  • 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
    Arrow kits contain bd eclipse needles for which bd has received reports of safety cover disengagement and needlestick injury. in some cases when the safety cover is pushed over the needle it disengages resulting in an exposed needle which can increase the risk of nsi. some customer reports indicate an audible "click" sound before the safety cover is locked (activated) followed by a second "click" sound when the safety cover is locked over the needle. this may potentially increase the risk of nsi if the user assumes the safety cover is locked after the initial "click.".

Device

PRESSURE INJECTABLE PICC KIT
  • Model / Serial
    Model Catalog: EU-05041-HPMSB (Lot serial: ALL); Model Catalog: EU-05052-HPMSB (Lot serial: ALL); Model Catalog: EU-04052-HPMSB (Lot serial: ALL); Model Catalog: EU-04041-HPMSB (Lot serial: ALL); Model Catalog: CDA-47702-P1A (Lot serial: ALL); Model Catalog: CDA-45703-P1A (Lot serial: ALL); Model Catalog: CDA-42802-P1A (Lot serial: ALL); Model Catalog: CDA-42703-P1A (Lot serial: ALL); Model Catalog: CA-47702-P1A (Lot serial: ALL); Model Catalog: CA-45703-P1A (Lot serial: ALL); Model Catalog: CA-42703-P1A (Lot serial: ALL); Model Catalog: CDA-29803-1A (Lot serial: ALL); Model Catalog: CDA-25123-1A (Lot serial: ALL); Model Catalog: EU-05541-HPMSB (Lot serial: ALL); Model Catalog: ASK-22702-CA (Lot serial: ALL); Model Catalog: ASK-45703-PRJ (Lot serial: ALL); Model Catalog: ASK-42703-PRJ (Lot serial: ALL); Model Catalog: CDA-45052-HPK1A (Lot serial: ALL); Model Catalog: CDA-45854-P1A (Lot serial: ALL); Model Catalog: CDA-42854-P1A (Lot serial: ALL); Model Catalog: CA-45854-P1A (Lot serial: ALL); Model Catalog:
  • Product Description
    PRESSURE INJECTABLE PICC KIT;AGB+ PRESSURE INJECTABLE MULTI-LUMEN CVC KIT;PERCUTANEOUS SHEATH INTRODUCER KIT WITH ARROWG+ARD BLUE SHEATH INTEGRAL HEMOSTASIS VALVE/SIDE PORT AND MAXIMAL BARRIER PRECAUTIONS;ARROWG+ARD BLUE LARGE BORE MULTI-LUMEN CVC KIT FOR
  • Manufacturer
    TELEFLEX MEDICAL CANADA INC.

Manufacturer

TELEFLEX MEDICAL CANADA INC.