Events

Recall of TRANSVERSE LAPAROTOMY PACKS

According to Health Canada (via FOI), this recall involved a device in Canada that was produced by CARDINAL HEALTH 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
    52123
  • Event Risk Class
    II
  • Event Initiated Date
    2018-03-06
  • 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
    Cardinal health presource kits were exposed to temperature variations during transportation which are outside the range of the supplier's approved labelling. as such these temperature excursions may have impacted the effectiveness of certain components within the kits.

Device

TRANSVERSE LAPAROTOMY PACKS
  • Model / Serial
    Model Catalog: SBA30TRNHJ (Lot serial: 467489); Model Catalog: SAN30CLSLR (Lot serial: 468870); Model Catalog: SBA30MNNLE (Lot serial: 469042); Model Catalog: SAN30CCSLH (Lot serial: 468563); Model Catalog: SLC30LCNLF (Lot serial: 468653); Model Catalog: SAN30CLCRE (Lot serial: 468870); Model Catalog: SAN30CCUA1 (Lot serial: 468870); Model Catalog: SAN30CCSLH (Lot serial: 468870); Model Catalog: SAN30CLSLR (Lot serial: 469135); Model Catalog: SAN30CLCRE (Lot serial: 469135); Model Catalog: SAN30CCUA1 (Lot serial: 469135); Model Catalog: SAN30CCSLH (Lot serial: 469135); Model Catalog: SAN30CLSLR (Lot serial: 468238); Model Catalog: SAN30CLCRE (Lot serial: 468238); Model Catalog: SAN30CCUA1 (Lot serial: 468238); Model Catalog: SAN30CCSLH (Lot serial: 468238); Model Catalog: SAN30CLSLR (Lot serial: 468563); Model Catalog: SAN30CLCRE (Lot serial: 468563); Model Catalog: SAN30CCUA1 (Lot serial: 468563); Model Catalog: SCV30EPUA1 (Lot serial: 467711); Model Catalog: SBA30LTNLE (Lot serial: 468401); Model Catalog:
  • Product Description
    TRANSVERSE LAPAROTOMY PACKS;CARDIAC CATHETERIZATION PACKS;MINOR LAPAROTOMY PACKS;LAP CHOLE PACKS;EP PACK;MINOR LITHOTONY PACKS;MAXIMAL BARRIER;ENSEMBLE PACEMAKER;KNEE PACKS;C SECTION PACK;CATHETERIZATION PACK;MAJOR LAPAROTOMY PACKS;ENSEMBLE CORONARY
  • Manufacturer
    CARDINAL HEALTH CANADA INC.

Manufacturer

CARDINAL HEALTH CANADA INC.
  • Manufacturer Address
    MISSISSAUGA
  • Manufacturer Parent Company (2017)
    Cardinal Health
  • Source
    HC