Events

Recall of HIP 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
    88596
  • Event Risk Class
    II
  • Event Initiated Date
    2017-11-13
  • 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 has recently been informed that zhende has issued a supplier device correction for 4x4" 16- ply x-ray gauze (cr-nxr4416) due to the potential for miscounted gauze. this gauze is found in cardinal health presource kits.

Device

HIP PACKS
  • Model / Serial
    Model Catalog: SOP30HPDTM (Lot serial: > 100 NUMBERS CONTACT MFG); Model Catalog: SCV30CAARA (Lot serial: > 100 NUMBERS CONTACT MFG); Model Catalog: SMA30LPDTF (Lot serial: > 100 NUMBERS CONTACT MFG); Model Catalog: SBA30CRUCI (Lot serial: > 100 NUMBERS CONTACT MFG); Model Catalog: SBA30CRCHG (Lot serial: > 100 NUMBERS CONTACT MFG); Model Catalog: SEN30MFHRD (Lot serial: > 100 NUMBERS CONTACT MFG); Model Catalog: SEN30ENRHJ (Lot serial: > 100 NUMBERS CONTACT MFG); Model Catalog: SEN30ENCRB (Lot serial: > 100 NUMBERS CONTACT MFG); Model Catalog: SEN30ENBUB (Lot serial: > 100 NUMBERS CONTACT MFG); Model Catalog: SEN30EESMB (Lot serial: > 100 NUMBERS CONTACT MFG); Model Catalog: SEN30EENRG (Lot serial: > 100 NUMBERS CONTACT MFG); Model Catalog: SAN30MNSCC (Lot serial: > 100 NUMBERS CONTACT MFG); Model Catalog: SCV30MANHJ (Lot serial: > 100 NUMBERS CONTACT MFG); Model Catalog: SMA30PGVRK (Lot serial: > 100 NUMBERS CONTACT MFG); Model Catalog: SMA30CSPNB (Lot serial: > 100 NUMBERS CONTACT MFG); Model Catalog: SMA
  • Product Description
    Presource Kits- Hip Packs;Presource Kits-CAROTID PACKS;Presource Kits-STERILE LAPAROSCOPY PACK;Presource Kits - BOWEL RESECTION LITHOTOMY PACKS;Presource Kits -MAXILLO MAJOR PACKS;Presource Kits-Basic Ent Pack;Presource Kits-MANIFOLD PACKS;Presource Kits-
  • Manufacturer
    CARDINAL HEALTH CANADA INC.

Manufacturer

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