Events

Recall of DELUXE WOUND CLOSURE INSTRUMENT PACK

According to Health Canada (via FOI), this recall involved a device in Canada that was produced by BUSSE HOSPITAL DISPOSABLES.

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
    98233
  • Event Risk Class
    II
  • Event Initiated Date
    2017-11-02
  • 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 reports that during routine review of stability samples results demonstrated the product did not meet the iodine estimate levels required to support 36 months expiration dating. aplicare has determined that the product(s) will instead support a 24 months expiration period. therefore busse has updated the expiration dates of the kits manufactured by busse that were affected by the aplicare expiration date revision.

Device

DELUXE WOUND CLOSURE INSTRUMENT PACK
  • Model / Serial
    Model Catalog: 756 (Lot serial: >10 CONTACT MFR); Model Catalog: 752 (Lot serial: 1520248); Model Catalog: 723 (Lot serial: >10 CONTACT MFR); Model Catalog: 724 (Lot serial: >10 CONTACT MFR); Model Catalog: 726 (Lot serial: >10 CONTACT MFR); Model Catalog: 820 (Lot serial: >10 CONTACT MFR); Model Catalog: 744 (Lot serial: >10 CONTACT MFR); Model Catalog: 758 (Lot serial: >10 CONTACT MFR)
  • Product Description
    DELUXE WOUND CLOSURE INSTRUMENT PACK;CUSTOM GENERAL SURGERY PROCEDURE KIT/TRAY;SUTURE REMOVAL KIT;I.V. START KITS;INCISION & DRAINAGE INSTRUMENT PACK
  • Manufacturer
    BUSSE HOSPITAL DISPOSABLES

Manufacturer

BUSSE HOSPITAL DISPOSABLES
  • Manufacturer Address
    HAUPPAUGE
  • Source
    HC