Events

Recall of PACEMAKER PACK

According to Health Canada (via FOI), this recall involved a device in Canada that was produced by MEDLINE CANADA CORPORATION.

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
    21521
  • Event Risk Class
    III
  • Event Initiated Date
    2017-01-23
  • 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
    Medline industries received a product advisory notice from bd concerning their eclipse needle. bd has received reports of safety cover disengagement and needlestick injury (nsi) for the bd eclipse needle. based on the customer reports 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. the bd eclipse needle is a component in several medline custom procedure packs. medline canada is therefore informing its customers of the bd advisory notice.

Device

PACEMAKER PACK
  • Model / Serial
    Model Catalog: DYNJ52472X (Lot serial: CONTACT MFG); Model Catalog: DYNJ46890X (Lot serial: CONTACT MFG); Model Catalog: DYNJ46856X (Lot serial: CONTACT MFG); Model Catalog: DYNJ46726X (Lot serial: CONTACT MFG); Model Catalog: DYNJ46729X (Lot serial: CONTACT MFG); Model Catalog: DYNJ46858X (Lot serial: CONTACT MFG); Model Catalog: DYNJ46877X (Lot serial: CONTACT MFG); Model Catalog: DYNJ46859X (Lot serial: CONTACT MFG); Model Catalog: DYNJ46745X (Lot serial: CONTACT MFG); Model Catalog: DYNJ48513X (Lot serial: CONTACT MFG); Model Catalog: DYNJ900660X (Lot serial: CONTACT MFG); Model Catalog: DYNJ46835X (Lot serial: CONTACT MFG); Model Catalog: DYNJ46860X (Lot serial: CONTACT MFG); Model Catalog: DYNJ41876X (Lot serial: CONTACT MFG); Model Catalog: DYNJ46736X (Lot serial: CONTACT MFG); Model Catalog: CDS982078X (Lot serial: CONTACT MFG); Model Catalog: DYNJ48536X (Lot serial: CONTACT MFG); Model Catalog: DYNJ37224X (Lot serial: CONTACT MFG); Model Catalog: DYNJ41910X (Lot serial: CONTACT MFG); Model Catalog:
  • Product Description
    PACEMAKER PACK;TVT WCH-LF;SHOULDER RVHS-LF;VAG HYS ANT PST REPAIR TEGH-LF;C SECTION TEGH-LF;MINOR PROCEDURE RVHS-LF;BREAST BIOPSY WCH-LF;MAJOR LIMB RVHS-LF;PACEMAKER TEGH-LF;ENDONASAL DCR MSH-LF;TMJ MSH-LF;C SECTION SJHC-LF;MINOR LIMB RVHS-LF;ANGIOGRAM LF
  • Manufacturer
    MEDLINE CANADA CORPORATION

Manufacturer

MEDLINE CANADA CORPORATION