Recall of EYE TRAYS/PACKS

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
    50774
  • Event Risk Class
    II
  • Event Initiated Date
    2017-11-17
  • Event Country
  • 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 field safety notice from beaver visitec concerning their beaver xstar safety knives. beaver visitec has received reports of the blade protective shield retracted (deactivated) upon receipt and inadvertent cuts to the user. the position of the shield (i.E. activated in place covering the blade or retracted) can be visualized through the clear cover of the tray that holds the knife. the beaver visitec beaver xstar safety knives are components in the above medline custom procedure pack. medline canada is therefore informing its customers of the beaver visitec field safety notice.

Device

  • Model / Serial
    Model Catalog: DYNJ41769X (Lot serial: 16JB8311); Model Catalog: DYNJ41769X (Lot serial: 16LB3606); Model Catalog: DYNJ41769X (Lot serial: 17MB2124); Model Catalog: DYNJ41769X (Lot serial: 179B1510); Model Catalog: DYNJ41769X (Lot serial: 17QB3629); Model Catalog: DYNJ41769X (Lot serial: 17SB0224); Model Catalog: DYNJ41769X (Lot serial: 17OB8381)
  • Product Description
    MEDLINE CUSTOM OPHTHALMOLOGY PACK CKHA-LF
  • Manufacturer

Manufacturer