Events

Recall of POWERPICC SOLO2 CATHETER SHERLOCK STYLET AND MICROINTRODUCER

According to Health Canada (via FOI), this recall involved a device in Canada that was produced by BARD 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
    125403
  • Event Risk Class
    III
  • Event Initiated Date
    2015-03-20
  • 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
    Bard has notified customers of the potential for scalpel cut/stick injury following a change in the safety scalpel component in some bard peripherally inserted central catheter (picc) kits. for users accustomed to the previous scalpel (bard-parker safety scalpel) a risk of improper use of the new safe-cut safety scalpel was noted. the customer letter described important differences in operation between the previous and current scalpel products.

Device

POWERPICC SOLO2 CATHETER SHERLOCK STYLET AND MICROINTRODUCER
  • Model / Serial
    Model Catalog: 1396118 (Lot serial: REYD0312); Model Catalog: 1295118 (Lot serial: REYD0312); Model Catalog: 1194118 (Lot serial: REYD0312); Model Catalog: 1396118 (Lot serial: REYD0126); Model Catalog: 1295118 (Lot serial: REYD0126); Model Catalog: 1194118 (Lot serial: REYD0126); Model Catalog: 1396118 (Lot serial: REYF0212); Model Catalog: 1295118 (Lot serial: REYF0212); Model Catalog: 1194118 (Lot serial: REYF0212); Model Catalog: 1396118 (Lot serial: REYE2229); Model Catalog: 1295118 (Lot serial: REYE2229); Model Catalog: 1194118 (Lot serial: REYE2229); Model Catalog: 1396118 (Lot serial: REYE1795); Model Catalog: 1295118 (Lot serial: REYE1795); Model Catalog: 1194118 (Lot serial: REYE1795); Model Catalog: 1396118 (Lot serial: REYD2021); Model Catalog: 1295118 (Lot serial: REYD2021); Model Catalog: 1194118 (Lot serial: REYD2021); Model Catalog: 1396118 (Lot serial: REYD1015); Model Catalog: 1295118 (Lot serial: REYD1015); Model Catalog: 1194118 (Lot serial: REYD1015); Model Catalog: 1396118 (Lot serial:
  • Product Description
    POWERPICC SOLO2 WITH SHERLOCK STYLET
  • Manufacturer
    BARD CANADA INC.

Manufacturer

BARD CANADA INC.