Events

Recall of COATED VICRYL RAPIDE SUTURE

According to Health Canada (via FOI), this recall involved a device in Canada that was produced by JOHNSON & JOHNSON MEDICAL PRODUCTS A DIV. OF JOHNSON & JOHNSON 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
    22212
  • Event Risk Class
    II
  • Event Initiated Date
    2017-09-08
  • 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
    Manufacturer has identified that certain lots of sizes 2-0 and 4-0 for vicryl rapidet suture exhibited suture damage due to a manufacturing equipment issue. the manufacturing equipment issue has been corrected. the medical assessment concluded that this situation could result in a potential superficial wound dehiscence or contribute to impaired wound healing but only occasionally and/or under unusual circumstances. manufacturer has not received any reports of adverse events associated with the product subject to this recall.

Device

COATED VICRYL RAPIDE SUTURE
  • Model / Serial
    Model Catalog: VR496 (Lot serial: AH7686); Model Catalog: VR945 (Lot serial: AH7686); Model Catalog: VR2297 (Lot serial: AH7711); Model Catalog: VR496 (Lot serial: AH7711); Model Catalog: VR945 (Lot serial: AH7711); Model Catalog: VR2297 (Lot serial: AJ0770); Model Catalog: VR496 (Lot serial: AJ0770); Model Catalog: VR945 (Lot serial: AJ0770); Model Catalog: VR2297 (Lot serial: AJ0794); Model Catalog: VR496 (Lot serial: AJ0794); Model Catalog: VR945 (Lot serial: AJ0794); Model Catalog: VR2297 (Lot serial: AH7686); Model Catalog: VR945 (Lot serial: AH7680); Model Catalog: VR496 (Lot serial: AH7680); Model Catalog: VR2297 (Lot serial: AH7680); Model Catalog: VR945 (Lot serial: AH7694); Model Catalog: VR496 (Lot serial: AH7694); Model Catalog: VR496 (Lot serial: AH6611); Model Catalog: VR945 (Lot serial: AH6611); Model Catalog: VR2297 (Lot serial: AH7694); Model Catalog: VR2297 (Lot serial: AH6611)
  • Product Description
    COATED VICRYL RAPIDE SUTURE
  • Manufacturer
    JOHNSON & JOHNSON MEDICAL PRODUCTS A DIV. OF JOHNSON & JOHNSON INC.

Manufacturer

JOHNSON & JOHNSON MEDICAL PRODUCTS A DIV. OF JOHNSON & JOHNSON INC.